The U.S. Nuclear Regulatory Commission (NRC) issued a Regulatory Issue Summary (RIS) entitled, RIS 2002-22, Supplement 1, “Clarification on Endorsement of Nuclear Energy Institute Guidance in Designing Digital Upgrades in Instrumentation and Control Systems.” This RIS supplement clarifies RIS 2002-22, which remains in effect. The NRC continues to endorse Nuclear Energy Institute (NEI)-01-01, as stated in RIS 2002-22 and clarified RIS 2002-22, Supplement 1. This RIS supplement clarifies the guidance in RIS 2002-22 for preparing and documenting qualitative assessments that licensees can use to develop written evaluations to address the criteria in NRC's regulations for digital instrumentation and control (I&C) modifications. This clarification is intended to reduce regulatory uncertainty for licensees applying the process set in the NRC's regulations and making digital I&C modifications without prior NRC approval.

DATES:

The RIS 2002-22, Supplement 1 is available as of June 25, 2018.

ADDRESSES:

Please refer to Docket ID NRC-2017-0154 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

• Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0154. Address questions about NRC dockets to Jennifer Borges; telephone: 301-287-9127; email: Jennifer.Borges@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document. RIS 2002-22, Supplement 1 is available under ADAMS Accession No. ML18143B633.

Supplement 1 of RIS 2002-22, “Clarification on Endorsement of Nuclear Energy Institute Guidance in Designing Digital Upgrades in Instrumentation and Control Systems” (ADAMS Accession No. ML18143B633), is intended for (1) all holders of operating licenses under part 50 of title 10 of the Code of Federal Regulations (CFR), “Domestic Licensing of Production and Utilization Facilities,” and (2) all holders of a combined license under 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.”

In 2002, the NRC staff issued RIS 2002-22 to notify addressees that the NRC staff had reviewed NEI-01-01 and was endorsing the report for use as guidance in designing and implementing digital upgrades to nuclear power plant instrumentation and control systems. Following the NRC staff's 2002 endorsement of NEI 01-01, holders of operating licenses have used this guidance in support of digital design modifications implemented without prior NRC approval in accordance with 10 CFR 50.59. The NRC inspections of documentation for these activities uncovered inconsistencies in the performance and documentation of engineering evaluations and associated technical bases for determinations on the 10 CFR 50.59(c)(2) evaluation criteria. This RIS Supplement clarifies the RIS 2002-22 endorsement of the NEI 01-01 guidance by providing additional guidance for developing and documenting “qualitative assessments” that are used to provide an adequate basis for a licensee's determination that a digital modification will exhibit a low likelihood of failure to support a conclusion when applying the evaluation criteria set in 10 CFR 50.59, that a license amendment is not needed.

The NRC published a notice of opportunity for public comment on a previous draft of this RIS in the Federal Register on July 3, 2017 (82 FR 30913). Subsequently, the NRC published a second notice of opportunity for public comment on the revised RIS on March 14, 2018 (83 FR 11154). As noted in the March 14, 2018 Federal Register notice (FRN), “[t]he NRC staff engaged in multiple communications with the public and stakeholders and continued internal discussions about the RIS. As a result of these efforts, the NRC has substantially rewritten the RIS. Due to the extensive nature of these revisions, and in light of this additional opportunity for comment, the NRC is not directly responding to each comment received in the previous comment period.”

The NRC received comments from seven commenters as a result of the March 14, 2018 FRN. The NRC considered all comments, some of which resulted in changes to the RIS, and discussed the evaluation of these comments and the resulting changes to the RIS in a memorandum that is publicly available in ADAMS under Accession No. ML18115A298.

As noted in 83 FR 20858 (May 8, 2018), this document is being published in the Rules section of the Federal Register to comply with publication requirements under 1 CFR chapter I.

The Coast Guard will enforce the Seattle Seafair Unlimited Hydroplane Race Special Local Regulation on Lake Washington, WA from 8 a.m. on July 31, 2018, through 8 p.m. on August 6, 2018, during hydroplane race times. This action is necessary to ensure public safety from the inherent dangers associated with high-speed races while allowing access for rescue personnel in the event of an emergency. During the enforcement period, no person or vessel will be allowed to enter the regulated area without the permission of the Captain of the Port, on-scene Patrol Commander or her Designated Representative.

DATES:

The regulations in 33 CFR 100.1301 will be enforced from 8 a.m. on July 31, 2018, through 8 p.m. on August 6, 2018.

The Coast Guard will enforce Seattle Seafair Unlimited Hydroplane Race special local regulations in 33 CFR 100.1301 from 8 a.m. on July 31, 2018, through 8 p.m. on August 6, 2018.

Under the provisions of 33 CFR 100.1301, the Coast Guard will restrict general navigation in the following area: All waters of Lake Washington bounded by the Interstate 90 (Mercer Island/Lacey V. Murrow) Bridge, the western shore of Lake Washington, and the east/west line drawn tangent to Bailey Peninsula and along the shoreline of Mercer Island.

The regulated area has been divided into two zones. The zones are separated by a line perpendicular from the I-90 Bridge to the northwest corner of the East log boom and a line extending from the southeast corner of the East log boom to the southeast corner of the hydroplane race course and then to the northerly tip of Ohlers Island in Andrews Bay. The western zone is designated Zone I, the eastern zone, Zone II. (Refer to NOAA Chart 18447).

The Coast Guard will maintain a patrol consisting of Coast Guard vessels, assisted by Coast Guard Auxiliary vessels, in Zone II. The Coast Guard patrol of this area is under the direction of the Coast Guard Patrol Commander (the “Patrol Commander”). The Patrol Commander is empowered to control the movement of vessels on the racecourse and in the adjoining waters during the periods this regulation is subject to enforcement. The Patrol Commander may be assisted by other federal, state and local law enforcement agencies.

Only vessels authorized by the Patrol Commander may be allowed to enter Zone I during the hours this regulation is in effect. Vessels in the vicinity of Zone I shall maneuver and anchor as directed by the Patrol Commander.

During the times in which the regulation is subject to enforcement, the following rules shall apply:

(1) Swimming, wading, or otherwise entering the water in Zone I by any person is prohibited while hydroplane boats are on the racecourse. At other times in Zone I, any person entering the water from the shoreline shall remain west of the swim line, denoted by buoys, and any person entering the water from the log boom shall remain within 10 feet of the log boom.

(2) Any person swimming or otherwise entering the water in Zone II shall remain within 10 feet of a vessel.

(3) Rafting to a log boom will be limited to groups of three vessels.

(4) Up to six vessels may raft together in Zone II if none of the vessels are secured to a log boom. Only vessels authorized by the Patrol Commander, other law enforcement agencies or event sponsors shall be permitted to tow other watercraft or inflatable devices.

(5) Vessels proceeding in either Zone I or Zone II during the hours this regulation is in effect shall do so only at speeds which will create minimum wake, 7 miles per hour or less. This maximum speed may be reduced at the discretion of the Patrol Commander.

(6) Upon completion of the daily racing activities, all vessels leaving either Zone I or Zone II shall proceed at speeds of 7 miles per hour or less. The maximum speed may be reduced at the discretion of the Patrol Commander.

(7) A succession of sharp, short signals by whistle or horn from vessels patrolling the areas under the direction of the Patrol Commander shall serve as signal to stop. Vessels signaled shall stop and shall comply with the orders of the patrol vessel; failure to do so may result in expulsion from the area, citation for failure to comply, or both.

The Captain of the Port may be assisted by other federal, state and local law enforcement agencies in enforcing this regulation.

This notice of enforcement is issued under authority of 33 CFR 100.1301 and 5 U.S.C. 552(a). If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice of enforcement, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

Notice of temporary deviation from regulations; request for comments, extension.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Flagler Memorial (SR A1A) Bridge, mile 1021.8, the Royal Park (SR 704) Bridge, mile 1022.6, and the Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the Atlantic Intracoastal Waterway, at West Palm Beach, Florida. This deviation will extend the test to change the drawbridge operation schedules to determine whether permanent changes to the schedules are needed. This deviation allows the Flagler Memorial, Royal Park and Southern Boulevard Bridges to operate on alternative schedules when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. This deviation is necessary to accommodate the increase in vehicular traffic when the presidential motorcade is in transit.

DATES:

This deviation is effective without actual notice from June 25, 2018 through 11:59 p.m. on August 29, 2018. For purposes of enforcement, actual notice will be used from 12:01 a.m. on June 1, 2018, until June 25, 2018.

Comments and relate material must reach the Coast Guard on or before July 25, 2018.

ADDRESSES:

You may submit comments identified by docket number USCG-2017-0273 using Federal eRulemaking Portal at http://www.regulations.gov.

See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

On August 17, 2017, the Coast Guard published a notice of deviation from drawbridge regulation with request for comments in the Federal Register (82 FR 39019) to test proposed changes. Three comments were received, which were in favor of the regulation changes. Due to delays in processing this proposed regulatory change, on March 6, 2018, the Coast Guard published a notice of deviation from regulations with request for comments extension in the Federal Register (82 FR 9431) to allow for additional time for the public to comment. Two comments were received; one in favor of the regulation change and one was not relevant to the regulation. On May 21, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FL in the Federal Register (83 FR 23398). The submission deadline for public comments related to that proposed rule is July 5, 2018. Due to unanticipated delays in processing this regulatory change, the Coast Guard finds it necessary to extend the test deviation to allow additional time for public comment. The changes to the operating schedules proposed in this deviation will coincide with the establishment of the Presidential Security Zone (82 FR 17295).

When the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago, drawbridge openings have caused traffic backups in the West Palm Beach area. The increase in traffic congestion occurs when the presidential motorcade is in transit, which closes the Southern Boulevard Bridge to vehicle and vessel traffic. This action requires through traffic to use the Flagler Memorial and Royal Park Bridges. The Mayor of Palm Beach has asked the Coast Guard and the bridge owner, Florida Department of Transportation, to test a change to the operating regulations of those bridges.

During this temporary deviation, the Flagler Memorial Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:15 p.m., 3:15 p.m., 4:15 p.m. and 5:15 p.m., weekdays only, if vessels are requesting an opening. The Royal Park Bridge is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:30 p.m., 3:30 p.m., 4:30 p.m. and 5:30 p.m., weekdays only, if vessels are requesting an opening. At all other times the bridges will operate per their normal schedules, published in 33 CFR 117.261(u) and (v), respectively.

The operating schedule of the Southern Boulevard Bridge, which is closest to Mar-a-Lago, will be allowed to remain closed to navigation whenever the presidential motorcade is in transit. At all other times the bridge shall open on the quarter and three-quarter hour, or as directed by the on-scene designated representative.

This test deviation will have an impact on marine traffic while alleviating some vehicle traffic backups. Tugs with tows are not exempt from this regulation. Vessels able to pass through the Flagler Memorial and Royal Park Bridges in the closed position may do so at any time. The bridges will be able to open for emergencies. The Southern Boulevard Bridge will be under the control of the on-scene designated representative.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

II. Public Participation and Request for Comments

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacynotice.

Documents mentioned in this notice as being available in this docket and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Lapalco Boulevard Bridge, Harvey Canal Route, mile 2.8, over the Gulf Intracoastal Waterway, in Harvey, LA. The deviation is necessary to accommodate maintenance and replacement of various bridge components. This deviation allows the bridge to remain in the closed-to-navigation position for two separate seven-day periods.

DATES:

This deviation is effective from 6 a.m. on July 23, 2018 through 6 a.m. on August 13, 2018.

ADDRESSES:

The docket for this deviation, USCG-2018-0408 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

The owner of the bridge, Jefferson Parish, has requested a temporary deviation from the operating schedule for the Lapalco Boulevard Bridge, Harvey Canal Route, mile 2.8 over the Gulf Intracoastal Waterway in Harvey, LA to remain in the closed-to-navigation position to marine traffic for maintenance and component replacement activities over two separate seven-day periods. The bascule span drawbridge has a vertical clearance of 45 feet above mean high water in the closed-to-navigation position.

The current operating schedule is set out in 33 CFR 117.451(a). This temporary deviation allows the bridge to remain in the closed-to-navigation position from 6 a.m. on July 23, 2018 through 6 a.m. on July 30, 2018, and from 6 a.m. on August 6, 2018 through 6 a.m. on August 13, 2018. This temporary deviation is necessary in order to replace the motors and brakes necessary for the operation of the bridge.

Navigation on the waterway consists mainly of tugs with tows, with some commercial fishing vessels and recreational craft. Vessels able to pass through the bridge in the closed to navigation position may do so at any time. The bridge will not be able to open for emergencies during these repairs. However, an alternate route is available via the Gulf Intracoastal Waterway Algiers Alternate Route. The Coast Guard will also inform the waterway users of the change in operating schedule for the bridge through our Local Notice and Broadcast Notices to Mariners so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of each of the effective time periods. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Coast Guard is establishing a temporary safety zone for navigable waters within a 420-foot radius of a portion of the St. Clair River, Port Huron, MI. This zone is necessary to protect spectators and vessels from potential hazards associated with the Blue Water Festival Fireworks.

DATES:

This temporary final rule is effective from 10 p.m. on July 21, 2018 through 10:30 p.m. on July 22, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0571 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this fireworks display in time to publish an NPRM. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 10 p.m. on July 21, 2018 through 10:30 p.m. on July 22, 2018 will be a safety concern to anyone within a 420-foot radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being displayed.

IV. Discussion of the Rule

This rule establishes a safety zone from 10 p.m. on July 21, 2018 through 10:30 p.m. on July 22, 2018. The safety zone will encompass all U.S. navigable waters of the St. Clair River, Port Huron, MI, within a 420-foot radius of position 42°58.838′ N, 082°25.194′ W (NAD 83). The safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 21, 2018. In the case of inclement weather on July 21, 2018, this safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 22, 2018. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the St. Clair River from 10 p.m. on July 21, 2018 through 10:30 p.m. on July 22, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less than one hour that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

(a) Location. A safety zone is established to include all U.S. navigable waters of the St. Clair River, Port Huron, MI, within a 420-foot radius of position 42°58.838′ N, 082°25.194′ W (NAD 83).

(b) Enforcement period. The regulated area described in paragraph (a) of this section will be enforced from 10 p.m. through 10:30 p.m. on July 21, 2018. In the case of inclement weather on July 21, 2018, this safety zone will be enforced from 10 p.m. to 10:30 p.m. on July 22, 2018. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

(c) Regulations. (1) No vessel or person may enter, transit through, or anchor within the safety zone unless authorized by the Captain of the Port Detroit (COTP), or his on-scene representative.

(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or his on-scene representative.

(3) The “on-scene representative” of COTP is any Coast Guard commissioned, warrant or petty officer or a Federal, State, or local law enforcement officer designated by or assisting the Captain of the Port Detroit to act on his behalf.

(4) Vessel operators shall contact the COTP or his on-scene representative to obtain permission to enter or operate within the safety zone. The COTP or his on-scene representative may be contacted via VHF Channel 16 or at (313) 568-9464. Vessel operators given permission to enter or operate in the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

The Coast Guard is establishing a temporary safety zone for navigable waters within a 350-foot radius of a portion of the Trenton Channel, Trenton, MI. This zone is necessary to protect spectators and vessels from potential hazards associated with the Roar on the River Fireworks.

DATES:

This temporary final rule is effective from 10 p.m. on July 21, 2018 through 11 p.m. on July 22, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0569 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

SUPPLEMENTARY INFORMATION:I. Table of AbbreviationsCFR Code of Federal RegulationsCOTP Captain of the Port DetroitDHS Department of Homeland SecurityFR Federal RegisterNPRM Notice of Proposed Rulemaking§ SectionU.S.C. United States CodeII. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this fireworks display in time to publish an NPRM. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 10 p.m. on July 21, 2018 through 11 p.m. on July 22, 2018 will be a safety concern to anyone within a 350-foot radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being displayed.

IV. Discussion of the Rule

This rule establishes a safety zone from 10 p.m. on July 21, 2018 through 11 p.m. on July 22, 2018. The safety zone will encompass all U.S. navigable waters of the Trenton Channel, Trenton, MI, within a 350-foot radius of position 42°07.5′ N, 083°10.45′ W (NAD 83). The safety zone will be enforced from 10 p.m. to 11 p.m. on July 21, 2018. In the case of inclement weather on July 21, 2018, this safety zone will be enforced from 10 p.m. to 11 p.m. on July 22, 2018. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Trenton Channel from 10 p.m. on July 21, 2018 through 11 p.m. on July 22, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone enforced for one hour that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

(a) Location. A safety zone is established to include all U.S. navigable waters of the Trenton Channel, Trenton, MI, within a 350-foot radius of position 42°07.5′ N, 083°10.45′ W (NAD 83).

(b) Enforcement period. The regulated area described in paragraph (a) of this section will be enforced from 10 p.m. to 11 p.m. on July 21, 2018. In the case of inclement weather on July 21, 2018, this safety zone will be enforced from 10 p.m. to 11 p.m. on July 22, 2018.

(c) Regulations. (1) No vessel or person may enter, transit through, or anchor within the safety zone unless authorized by the Captain of the Port Detroit (COTP), or his on-scene representative.

(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or his on-scene representative.

(3) The “on-scene representative” of COTP is any Coast Guard commissioned, warrant or petty officer or a Federal, State, or local law enforcement officer designated by or assisting the Captain of the Port Detroit to act on his behalf.

(4) Vessel operators shall contact the COTP or his on-scene representative to obtain permission to enter or operate within the safety zone. The COTP or his on-scene representative may be contacted via VHF Channel 16 or at (313) 568-9464. Vessel operators given permission to enter or operate in the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

The Coast Guard is establishing a temporary safety zone for navigable waters within a 420-foot radius of a portion of Lake St. Clair, Grosse Pointe Shores, MI. This zone is necessary to protect spectators and vessels from potential hazards associated with the Detroit Symphony Orchestra Fireworks.

DATES:

This temporary final rule is effective from 10 p.m. on July 13, 2018 through 11 p.m. on July 14, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0585 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

SUPPLEMENTARY INFORMATION:I. Table of AbbreviationsCFR Code of Federal RegulationsCOTP Captain of the Port DetroitDHS Department of Homeland SecurityFR Federal RegisterNPRM Notice of Proposed Rulemaking§ SectionU.S.C. United States CodeII. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this fireworks display in time to publish an NPRM. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 10 p.m. on July 13, 2018 through 11 p.m. on July 14, 2018 will be a safety concern to anyone within a 420-foot radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being displayed.

IV. Discussion of the Rule

This rule establishes a safety zone from 10 p.m. on July 13, 2018 through 11 p.m. on July 14, 2018. The safety zone will encompass all U.S. navigable waters of Lake St. Clair, Grosse Pointe Shores, MI, within a 420-foot radius of position 42°27.25′ N, 082°51.95′ W (NAD 83). The safety zone will be enforced from 10 p.m. to 11 p.m. on July 13, 2018 and July 14, 2018. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of Lake St. Clair from 10 p.m. on July 13, 2018 through 11 p.m. on July 14, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one hour that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

(a) Location. A safety zone is established to include all U.S. navigable waters of Lake St. Clair, Grosse Pointe Shores, MI, within a 420-foot radius of position 42°27.25′ N, 082°51.95′ W (NAD 83).

(b) Enforcement period. The regulated area described in paragraph (a) of this section will be in effect from 10 p.m. on July 13, 2018 through 11 p.m. on July 14, 2018. The safety zone will be enforced from 10 p.m. to 11 p.m. on July 13, 2018 and July 14, 2018.

(c) Regulations. (1) No vessel or person may enter, transit through, or anchor within the safety zone unless authorized by the Captain of the Port Detroit (COTP), or his on-scene representative.

(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or his on-scene representative.

(3) The “on-scene representative” of COTP is any Coast Guard commissioned, warrant or petty officer or a Federal, State, or local law enforcement officer designated by or assisting the Captain of the Port Detroit to act on his behalf.

(4) Vessel operators shall contact the COTP or his on-scene representative to obtain permission to enter or operate within the safety zone. The COTP or his on-scene representative may be contacted via VHF Channel 16 or at (313) 568-9464. Vessel operators given permission to enter or operate in the regulated area must comply with all directions given to them by the COTP or his on-scene representative.

The Coast Guard will enforce the annual Seafair Air Show Performance safety zone on Lake Washington, Seattle, WA daily, from 8 a.m. until 4 p.m., from August 2, 2018, through August 5, 2018. This action is necessary to ensure the safety of the public from inherent dangers associated with these annual aerial displays. During the enforcement period, no person or vessel may enter or transit this safety zone unless authorized by the Captain of the Port or his designated representative.

DATES:

The regulations in 33 CFR 165.1319 will be enforced daily, from 8 a.m. until 4 p.m., from August 2, 2018, through August 5, 2018.

The Coast Guard will enforce the Seafair Air Show Performance safety zone in 33 CFR 165.1319 daily, from 8 a.m. until 4 p.m., from August 2, 2018, through August 5, 2018 unless canceled sooner by the Captain of the Port.

Under the provisions of 33 CFR 165.1319, the following area is designated as a safety zone: All waters of Lake Washington, Washington State, south of the Interstate 90 bridge, west of Mercer Island, and north of Seward Park. The specific boundaries of the safety zone are listed in 33 CFR 165.1319(b).

In accordance with the general regulations in 33 CFR part 165, subpart C, no person or vessel may enter or remain in the zone except for support vessels and support personnel, vessels registered with the event organizer, or other vessels authorized by the Captain of the Port or Designated Representatives. Vessels and persons granted authorization to enter the safety zone must obey all lawful orders or directions made by the Captain of the Port or his designated representative.

The Captain of the Port may be assisted by other federal, state and local law enforcement agencies in enforcing this regulation.

In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide the maritime community with advanced notification of the safety zone via the Local Notice to Mariners and marine information broadcasts on the day of the event. If the COTP determines that the safety zone need not be enforced for the full duration stated in this notice of enforcement, she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

The Coast Guard will enforce four safety zones for annual firework displays in the Captain of the Port, Puget Sound Zone during the dates and times noted under SUPPLEMENTARY INFORMATION. This action is necessary to prevent injury and to protect life and property of the maritime public from the hazards associated with the firework displays. During the enforcement periods, entry into, transit through, mooring, or anchoring within these safety zones is prohibited unless authorized by the Captain of the Port, Puget Sound or their Designated Representative.

DATES:

The regulations in 33 CFR 165.1332 will be enforced for the four safety zones listed under SUPPLEMENTARY INFORMATION from 5 p.m. on July 4, 2018, through 1 a.m. on July 5, 2018.

The Coast Guard will enforce regulations in 33 CFR 165.1332 for the following four safety zones established for Annual Fireworks Displays within the Captain of the Port, Puget Sound Area of Responsibility. These regulations will be enforced from 5 p.m. on July 4, 2018, through 1 a.m. on July 5, 2018, at the following locations:

The special requirements listed in 33 CFR 165.1332(b) apply to the activation and enforcement of these safety zones. All vessel operators who desire to enter the safety zone must obtain permission from the Captain of the Port or their Designated Representative by contacting the Coast Guard Sector Puget Sound Joint Harbor Operations Center (JHOC) on VHF Ch 13 or Ch 16 or via telephone at (206) 217-6002. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice of enforcement is issued under authority of 33 CFR 165.1332 and 5 U.S.C. 552 (a). In addition to the publication of this document in the Federal Register, the Coast Guard will provide the maritime community with extensive advanced notification of enforcement of these safety zones via the Local Notice to Mariners.

The Department of Veterans Affairs (VA) adopts as final, with no changes, a proposed rule amending its medical regulations related to hospital care and medical services in foreign countries. We simplified and clarified the scope of these regulations, address medical services provided to eligible veterans in the Republic of the Philippines, and removed provisions related to grants to the Republic of the Philippines that are no longer supported by statutory authority. VA also amends its medical regulations related to filing claims for reimbursement of medical expenses incurred for VA care not previously authorized. We provided a 60-day period to receive comments from the public on the proposed changes, and received no comments. VA adopts the proposed rule as final, with no changes.

Section 1724 of title 38 United States Code (U.S.C.) prohibits VA from furnishing hospital care or medical services outside any State except under specific circumstances. VA is authorized under 38 U.S.C. 1724(b)(1) to furnish care and services to an eligible veteran outside any State if VA “determines that such care and services are needed for the treatment of a service-connected disability of the veteran or as part of a rehabilitation program under chapter 31 of this title.” VA furnishes health care to eligible veterans in the Republic of the Philippines under this authority. In addition, 38 U.S.C. 1724(c) provides that “within the limits” of the Veterans Memorial Medical Center at Manila, Republic of the Philippines, VA may enter into contracts to furnish necessary hospital care to a veteran for any non-service-connected disability if such veteran is unable to defray the expenses of necessary hospital care. VA may also operate an outpatient clinic in the Republic of the Philippines to furnish necessary medical services to a veteran who has a service-connected disability. 38 U.S.C. 1724(e). Several sections of title 38 Code of Federal Regulations (CFR) part 17 address VA's authority to provide for hospital care and medical services for eligible veterans outside the United States, as well as submission of claims for reimbursement for services obtained from community care providers outside the United States.

On January 31, 2018, VA proposed to revise or amend these regulations to consolidate similar content, clarify provisions, and ensure that these regulations reflect current VA practice and statutory authority. (83 FR 4454). We proposed simplifying language in § 17.35 to make it easier to understand, adding a new paragraph (b) to address hospital care and outpatient services provided to eligible veterans in the Republic of the Philippines as authorized in 38 U.S.C. 1724, and paragraph (c) to provide guidance on which sections of part 17 apply to claims for payment or reimbursement of services not previously authorized by the Foreign Medical Program. We proposed amending § 17.125 which focuses on filing claims. We proposed stating that in those cases where VA payment for such services has not been authorized in advance, claims for payment for such health care services provided in a State should be submitted to the VA medical facility nearest to where those services were provided. We also proposed amending that section to provide specific guidance on where and how to file claims.

We proposed removing §§ 17.140 and 17.141 as the subject matter of delegation of authority would be covered by proposed revisions to § 17.125. Finally, we proposed removing §§ 17.350 through 17.370 which addressed grants to the Republic of the Philippines, as our authority to provide these grants under 38 U.S.C. 1732(b) has expired. VA still retains authority under 38 U.S.C. 1731 to assist the Republic of the Philippines in fulfilling its responsibility in providing medical care and treatment for Commonwealth Army veterans and new Philippine Scouts in need of such care and treatment for service-connected disabilities and non-service-connected disabilities under certain conditions.

We provided a 60-day period to the public to comment on the proposed rule. The comment period closed April 2, 2018, and we received no comments. Based on the rationale set forth in the proposed rule and in this document, VA is adopting the provisions of the proposed rule as a final rule with no changes.

Effect of Rulemaking

Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

Paperwork Reduction Act

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Regulatory Flexibility Act

The Secretary hereby certifies that this final regulatory amendment does not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rulemaking does not directly affect any small entities. Only VA beneficiaries and certain community care providers would be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is be exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders 12866, 13563, and 13771

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action and determined that the action is not a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 through FYTD. [For information about economically significant regulations, see Impact Analysis Procedures guide on the 00REG intranet site.]

Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment, or otherwise promulgates, a new regulation. In furtherance of this requirement, section 2(c) of E.O. 13771 requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. This final rule is not subject to the requirements of E.O. 13771 because there is no incremental cost associated with this rule.

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This final rule has no such effect on State, local, or tribal governments, or on the private sector.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on June 19, 2018, for publication.

(a) Under the VA Foreign Medical Program, VA may furnish hospital care and outpatient services to any veteran outside of the United States, without regard to the veteran's citizenship:

(1) If necessary for treatment of a service-connected disability, or any disability associated with and held to be aggravating a service-connected disability;

(2) If the care and services are furnished to a veteran participating in a rehabilitation program under 38 U.S.C. chapter 31 who requires care and services for the reasons enumerated in § 17.47(i)(2).

(b) Under the Foreign Medical Program, the care and services authorized under paragraph (a) of this section are available in the Republic of the Philippines to a veteran who meets the requirements of paragraph (a) of this section. VA may also provide outpatient services to a veteran referenced in paragraph (a)(1) in the VA outpatient clinic in Manila for the treatment of such veteran's service-connected conditions within the limits of the clinic. Non-service connected conditions of a veteran who has a service-connected disability may be treated within the limits of the VA outpatient clinic in Manila.

(c) Claims for payment or reimbursement for services not previously authorized by VA under this section are governed by §§ 17.123-17.127 and 17.129-17.132.

3. Revise § 17.125 to read as follows:§ 17.125 Where to file claims.

Generally, VA must preauthorize VA payment for health care services provided in the community when such care is provided in a State as that term is defined in 38 U.S.C. 101(20).

(a) Where VA payment for such services has not been authorized in advance, claims for payment for such health care services provided in a State should be submitted to the VA medical facility nearest to where those services were provided.

(c) All other claims for payment for hospital care and outpatient services authorized under § 17.35(a) and provided outside a State must be submitted to the Foreign Medical Program, P.O. Box 469061, Denver, CO 80246-9061.

The Environmental Protection Agency (EPA) is approving the State Implementation Plan (SIP) submittal from the Alaska Department of Environmental Conservation (Alaska DEC) demonstrating that the SIP meets certain interstate transport requirements of the Clean Air Act (CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated in 2010 for nitrogen dioxide (NO2) and sulfur dioxide (SO2). The EPA has determined that Alaska's SIP contains adequate provisions to ensure that air emissions in Alaska do not significantly contribute to nonattainment or interfere with the maintenance of the 2010 NO2 and SO2 NAAQS in any other state.

DATES:

This final rule is effective July 25, 2018.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2016-0590. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through https://www.regulations.gov, or please contact the person identified in the For Further Information Contact section for additional availability information.

FOR FURTHER INFORMATION CONTACT:

John Chi at (206) 553-1185, or chi.john@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document whenever “we,” “us,” or “our” is used, it is intended to refer to the EPA. Information is organized as follows:

Table of ContentsI. BackgroundII. Final ActionIII. Statutory and Executive Order ReviewsI. Background

The public comment period for the EPA's proposed action ended on May 23, 2018. We received no adverse comments. There were four electronic comments submitted through https://www.regulations.gov. We reviewed the comments and we have determined that none are germane to this action. Therefore, we are finalizing our action as proposed.

II. Final Action

The EPA is approving Alaska's March 10, 2016, SIP submission as demonstrating sources in Alaska do not significantly contribute to nonattainment, or interfere with maintenance, of the 2010 NO2 and SO2 NAAQS in any other state. Based on our review, we find the Alaska SIP meets the CAA section 110(a)(2)(D)(i)(I) interstate transport requirements for the 2010 NO2 and SO2 NAAQS.

III. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and it will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS1. The authority citation for part 52 continues to read as follows:Authority:

42 U.S.C. 7401 et seq.

Subpart C—Alaska2. In § 52.70, the table in paragraph (e) is amended by adding an entry for “Interstate Transport Requirements—2010 NO2 and 2010 SO2 NAAQS” after the entry for “Infrastructure Requirements—2010 SO2 NAAQS” to read as follows:§ 52.70 Identification of plan.

The Environmental Protection Agency (EPA) is taking final action to approve changes to the South Carolina State Implementation Plan (SIP) to revise definitions and a regulation for open burning. EPA is approving portions of SIP revisions submitted by the State of South Carolina, through the South Carolina Department of Health and Environmental Control (SC DHEC) on the following dates: July 18, 2011, June 17, 2013, April 10, 2014, August 8, 2014, and July 27, 2016. These actions are being taken pursuant to the Clean Air Act (CAA or Act).

DATES:

This rule will be effective July 25, 2018.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0387. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

On July 18, 2011, June 17, 2013, April 10, 2014, August 8, 2014, and July 27, 2016, SC DHEC submitted SIP revisions to EPA for approval that involve changes to South Carolina's SIP regulations to add definitions, make administrative and clarifying amendments, and correct typographical errors. These SIP submittals make changes to several air quality rules in South Carolina Code of Regulations Annotated (S.C. Code Ann. Regs.). The changes EPA is approving into the SIP in this action modify portions of Regulation 61-62.1 “Definitions and General Requirements” at Section I—“Definitions” and make a revision to Regulation 61-62.2,—“Prohibition of Open Burning.”

At this time, EPA is not acting on the changes detailed in Table 1 below, which include portions of several SIP submittals that EPA has approved previously. EPA will address all remaining requested changes to the South Carolina SIP in the relevant SIP submissions as listed below in a separate action.

1 In its July 18, 2011, submittal, South Carolina is removing entirely a rule for setting alternative emission limitations at Regulation 61-62.5, Standard No. 6, “Alternative Emission Limitation Options (`Bubble'),” and replacing it with “Reserved.” This change is not presently before EPA for action because Regulation 61-62.5, Standard No. 6 is not part of the State's federally approved SIP. EPA rescinded the original approval of this regulation and disapproved a further revision to it on March 8, 1995 (60 FR 12700).

2 EPA did not approve one portion of 61-62.5, Standard No. 7 from the April 10, 2014 submittal making revisions to certain provisions corresponding to EPA's May 1, 2007 rule regarding ethanol production facilities (72 FR 24060). EPA will evaluate this portion of the April 10, 2014 submittal in a separate action.

On August 21, 2017, EPA published a proposed rulemaking (82 FR 39551), which accompanied a direct final rulemaking (82 FR 39537) published on the same date. The proposed rule proposed to approve the portions of South Carolina's SIP revisions described above. It also stated that if EPA received adverse comment on the direct final rule, then the Agency would withdraw the direct final rule and address public comments received in a subsequent final rule based on the proposed rule. EPA received one adverse comment letter from a Commenter regarding the portion of the direct final rule revising Regulation 61-62.1, Section I—“Definitions,” and the revision to Regulation 61-62.2,—“Prohibition of Open Burning,” and EPA accordingly withdrew those portions of the direct final rule proposing to approve changes to these rules on October 13, 2017 (82 FR 47636). After considering the adverse comments, EPA is now taking final action, based on the proposed rule, on the portions of South Carolina's SIP revisions modifying Regulation 61-62.1, Section I and Regulation 61-62.2, as described above.

III. Analysis of South Carolina's SubmittalsA. Definitions

South Carolina is amending its list of applicable definitions related to the regulation of air quality at Regulation 61-62.1, Section I—“Definitions.” The July 18, 2011, submittal makes several changes to the definitions as follows: (1) Adds a definition for “CAA [Clean Air Act];” (2) adds definitions for “PM2.5,” or fine particulate matter with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers, and “PM2.5 emissions;” (3) revises the definition of “fugitive emissions” to match the federal definition at 40 CFR 51.165(a)(1)(ix), 40 CFR 51.166(b)(20), and 40 CFR 52.21(b)(20); and (4) makes other clarifying and administrative edits to definitions throughout Section I, including renumbering. The June 17, 2013, submittal further revises the definitions to make several administrative edits only.

The April 10, 2014, submittal makes one revision to the definitions at Regulation 61-62.1, Section I.94.—“Volatile Organic Compound (VOC),” to add a compound to the list of compounds determined by EPA to have negligible photochemical reactivity and therefore exempted from being considered a VOC, consistent with the federal definition. This revision in the April 10, 2014, submittal was superseded by another revision to the definition of VOC at I.94. in the August 8, 2014, submittal. This latter submittal changes the format of the definition of VOC at I.99., renumbered from I.94., to incorporate directly the list of compounds exempted by EPA from the federal regulatory definition of VOC by making an explicit reference to the definition at 40 CFR 51.100(s). The August 8, 2014, submittal also revises Section I by: (1) Adding definitions for “Code of Federal Regulations (CFR),” “NAICS [North American Industrial Classification System] Code,” and “SIC [Standard Industrial Classification] Code”; and (2) making administrative changes throughout.

Finally, the July 27, 2016, submittal makes subsequent revisions to Section I to add the definition of “emission” and makes administrative edits throughout. EPA has reviewed the changes made to South Carolina's definitions and is approving the aforementioned changes to Regulation 61-62.1, Section I into the SIP pursuant to CAA section 110 because the revisions are consistent with the CAA.

B. Open Burning

South Carolina is making a minor change to its rules covering open burning at Regulation 61-62.2—“Prohibition of Open Burning.” The April 10, 2014, submittal revises the regulation to make an administrative edit to a referenced manual only and makes no substantive changes. Specifically, the State is changing the font for the referenced manual for internal consistency. EPA has reviewed this purely administrative change made to South Carolina's rules for open burning and is approving the aforementioned change to Regulation 61-62.2 into the SIP pursuant to CAA section 110.

IV. Response to Comments

As noted above, EPA previously proposed to approve these changes, and others, to the South Carolina SIP on August 21, 2017 (82 FR 39551), along with a direct final rule published the same date (82 FR 39537). EPA received adverse comments from a Commenter regarding the portions of the direct final rule revising Regulation 61-62.1, Section I—“Definitions,” and the revision to Regulation 61-62.2,—“Prohibition of Open Burning,” and EPA accordingly withdrew those portions of the direct final rule on October 13, 2017 (82 FR 47636). EPA's responses to the adverse comments are below.

A. Definitions

The Commenter stated that South Carolina's definition of PM2.5 “should also include condensable and filterable PM.” South Carolina's SIP, under Regulation 61-62.1, Section I, defines PM2.5 as “[p]articulate matter with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers emitted to the ambient air as measured by a reference method based on Appendix L of 40 CFR 50 and designated in accordance with 40 CFR 53 or by an equivalent method designated in accordance with 40 CFR 53.” This definition is consistent with the way EPA uses the term in federal regulations. For example, PM2.5 is defined in the National Ambient Air Quality Standards as “particles with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers.” (See 40 CFR 50.7, 50.13 and 50.18.) Therefore, EPA disagrees with the Commenter's implication that South Carolina's definition of PM2.5 is not sufficient.

Although the Commenter did not mention South Carolina's definition of “PM2.5 emissions,” EPA notes that the State has added this term to R. 61-62.1 and defines it as “[f]inely divided solid or liquid material with an aerodynamic diameter less than or equal to a nominal 2.5 micrometers emitted to the ambient air as measured by a reference method approved by the Department, with concurrence of the U.S. Environmental Protection Agency.” With regard to “filterable PM” as mentioned by the Commenter, this component is included in the definition as “[f]inely divided solid . . . material” emitted to the ambient air. With regard to “condensable PM” as mentioned by the Commenter, South Carolina's definition differs from the federal definition of “direct PM2.5 emissions” 3 in that it does not specify the inclusion of “condensable PM2.5 emissions.” However, South Carolina's definition is sufficient for purposes of the State's SIP because, as explained below, the condensable component of source PM2.5 emissions will be included whenever a determination of a source's PM2.5 emissions is required.

3 Under the federal definition, “direct PM2.5 emissions” means solid or liquid particles emitted directly from an air emissions source or activity, or reaction products of gases emitted directly from an air emissions source or activity which form particulate matter as they reach ambient temperatures. Direct PM2.5 emissions include filterable and condensable PM2.5 emissions composed of elemental carbon, directly emitted organic carbon, directly emitted sulfate, directly emitted nitrate, and other organic or inorganic particles that exist or form through reactions as emissions reach ambient temperatures (including but not limited to crustal material, metals, and sea salt). 40 CFR 51.1000.

The inclusion of the condensable component in determining a source's PM2.5 emissions is driven by the applicable source test method(s) required under a relevant rule. First, South Carolina's federally approved SIP includes emission limits for “PM” but does not include emission limits for “PM2.5.” Therefore, “particulate matter emissions” (as defined in the South Carolina SIP), not “PM2.5 emissions,” is the term that is relevant for the purpose of determining a source's status of compliance with applicable PM emission limits of the South Carolina SIP. Second, South Carolina's PSD rules (which apply throughout the State) and Nonattainment New Source Review rules (which do not currently apply for PM2.5 in the State) both require sources to include the condensable portion of PM2.5 emissions. (See definitions of “Regulated NSR pollutant” at Regulation 61-62.5, Standard No. 7(b)(44)(i)(a) and Standard No. 7.1(c)(13)(D), respectively.) 4 Third, under federal rules such as the New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAPs), whether the condensable PM2.5 component must be measured is dictated by the testing methods that are specified to apply under those rules. Finally, with regard to emissions inventories, EPA has provided guidance to assist states in appropriately accounting for the condensable PM2.5 component in making annual reports of PM2.5 emissions.5 Moreover, the federal provisions regarding regular emissions inventory reporting at subpart A to part 51 require states to include the condensable and filterable portions of both PM2.5 and PM10 as applicable in the triennial reports of annual emissions for all sources and the annual reports of larger stationary source emissions. See 40 CFR 51.15(a)(1)(vi)-(vii).

4 The specific adoption of condensable PM2.5 as a regulated NSR pollutant was included in a March 14, 2011, SIP revision, which was approved on June 23, 2011 (76 FR 36875), and corrected for Standard No. 7 on August 10, 2017 (82 FR 37299).

South Carolina's definition of “PM2.5” is consistent with EPA's definition of the term. In addition, as discussed above, omitting the phrase “condensable PM2.5 emissions” from South Carolina's definition of “PM2.5 emissions” has no effect on the State's implementation of its PM2.5 program because the South Carolina SIP currently has no limits on “PM2.5 emissions” and because the other programs that regulate particulate matter specify the required source test methods, and those methods require measurement of the condensable component in determining a source's PM2.5 emissions. Accordingly, EPA considers South Carolina's definitions of these terms approvable under the CAA.

B. Open Burning

The Commenter suggests that EPA cannot approve changes to South Carolina's open burning rules if the rules do not apply “at all times.” EPA notes that no substantive change was made to the SIP-approved rule at Regulation 61-62.2, Prohibition of Open Burning. The only change made in the April 10, 2014, submittal was a change to the font from italics to non-italics for a referenced manual within the regulation. As stated in the proposed rule (82 FR 39551, August 21, 2017), EPA proposed to approve changes to the South Carolina SIP submitted by SC DHEC. The existing text of Regulation 61-62.2 is already part of South Carolina's federally approved SIP, and only the revision to the rule (i.e., the font change) was subject to comment through the proposal action. The change that was made is purely administrative in nature, and the Commenter has not raised a concern relevant to the revision. Nevertheless, EPA finds that Regulation 61-62.2 adequately prescribes the conditions under which open burning is allowed or prohibited. The only provisions of this rule related to timing are 62.2.E.6., 62.2.G.4. and 62.2.G.5., which are restrictions, not relaxations, on when open burning may be conducted in the State.

EPA received no additional comments regarding the changes to Regulation 61-62.1, Section I nor to the change made to Regulation 61-62.2. The public comments received are located in the Docket for this final action at www.regulations.gov.

V. Incorporation by Reference

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of South Carolina Regulation 61-62.1, Section I—“Definitions,” effective June 24, 2016, which revises definitions applicable to the SIP, and Regulation 61-62.2, “Prohibition of Open Burning,” effective December 27, 2013, which revises formatting for consistency. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State's implementation plan, have been incorporated by reference by EPA into that plan, are fully federally-enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.6

6 62 FR 27968 (May 22, 1997).

VI. Final Action

This is a final action based on the proposed rule (82 FR 39551). For the reasons discussed above, EPA is approving the aforementioned changes to the South Carolina SIP, submitted on July 18, 2011, June 17, 2013, April 10, 2014, August 8, 2014, and July 27, 2016, because they are consistent with the CAA and federal regulations.

VII. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this final action for the State of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have substantial direct effects on an Indian Tribe. The Catawba Indian Nation Reservation is located within the boundary of York County, South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS1. The authority citation for part 52 continues to read as follows:Authority:

42.U.S.C. 7401 et seq.

Subpart PP—South Carolina2. In § 52.2120, the table in paragraph (c) is amended by revising under “Regulation No. 62.1” the entry “Section I” and the entry “Regulation No. 62.2” to read as follows:§ 52.2120 Identification of plan.

(c) * * *

Air Pollution Control Regulations for South CarolinaState citationTitle/subjectState

The Environmental Protection Agency (EPA) is taking final action to approve changes to the South Carolina State Implementation Plan (SIP) to revise miscellaneous rules covering air pollution control standards. EPA is approving portions of SIP revisions submitted by the State of South Carolina, through the South Carolina Department of Health and Environmental Control (SC DHEC), on the following dates: October 1, 2007, July 18, 2011, June 17, 2013, August 8, 2014, July 27, 2016, and November 4, 2016. These actions are being taken pursuant to the Clean Air Act (CAA or Act).

DATES:

This rule will be effective July 25, 2018.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2017-0385. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

On October 1, 2007, July 18, 2011, June 17, 2013, August 8, 2014, July 27, 2016, and November 4, 2016, SC DHEC submitted SIP revisions to EPA for approval that involve changes to South Carolina's SIP regulations to make administrative and clarifying amendments, revise regulations, and correct typographical errors. These SIP submittals make changes to several air quality rules in the South Carolina Code of Regulations Annotated (S.C. Code Ann. Regs.). The changes EPA is approving into the SIP in this action modify portions of Regulation 61-62.5, Standard No. 1—Emissions From Fuel Burning Operations and Regulation 61-62.5, Standard No. 4—Emissions From Process Industries. EPA is not acting on other changes that are included in these submittals. EPA will act on those changes in separate actions.

1 EPA is taking final action to approve the revisions in Section I, with a state effective date of June 27, 2014. EPA has two revisions pertaining to subparagraph C “Special Provisions” submitted by the State on July 18, 2011, and August 12, 2015, with state effective dates of May 27, 2011 and June 26, 2015, respectively, and will address these changes in a separate action.

2 EPA is taking final action to approve the revisions in Section IV, with the exception of subparagraph B “Continuous Opacity Monitor Reporting Requirements,” submitted by the State on August 8, 2014 with a state effective date of June 27, 2014. EPA will address revisions in subparagraph B, also in an August 12, 2015, submittal, in a separate action.

The November 4, 2016, submittal makes typographical corrections under Section IV—Opacity Reporting Requirements.3 EPA has reviewed the aforementioned changes to South Carolina's Regulation 61-62.5, Standard No. 1 and is approving the changes into the SIP pursuant to CAA section 110.

3 The November 4, 2016, submittal with a state effective date of September 23, 2016, would supersede the 2014 revision with the exception of subparagraph B as mentioned in footnote #2.

South Carolina is amending multiple sections at Regulation 61-62.5, Standard No. 4—Emissions from Process Industries. The October 1, 2007, submittal removes Section IV—Portland Cement Manufacturing from the SIP. This rule contains particulate matter (PM) emission limits for cement kilns with a production rate of up to 120 tons per hour and it establishes a 20 percent allowable stack opacity limit for certain components of Portland cement plants. SC DHEC states that there are no Portland cement plants operating at 120 tons per hour or less in the State because it is not economically feasible. SC DHEC asserts that removing this rule would not create a relaxation as there are no applicable sources subject to this regulation. Additionally, should such a source start operation, it would be subject to more stringent PM emissions limits in New Source Performance Standards (NSPS) subpart F (Standards of Performance for Portland Cement Plants).

The July 18, 2011, submittal amends Section V—Cotton Gins by removing established specific emission limits based on production rate (output) of bales of cotton per hour and replacing that with specific, measurable performance requirements and operating standards.4 SC DHEC considered CAA section 110(l) in making this change. SC DEHC explains that the rule development is based on best management practices outlined in the United States Department of Agriculture's Cotton Ginners Handbook, staff experience with effective emission reduction techniques, the review of other state regulations on cotton gins, and several discussions with the affected industry. The new rule assures a greater degree of control of these emissions than that which would result from the existing process weight rate curve and also allows the State to more effectively determine compliance. The revised rule requires enforceable control of emissions from specific point sources in the ginning process rather than an allowable emission rate, and it establishes requirements to minimize fugitive emissions from various sources at cotton ginning facilities. The revised rule also sets applicable requirements for good housekeeping practices in the gin yard, weekly monitoring of control efficiency, recordkeeping, and reporting. The revised regulation will provide for improved emissions control through practicably enforceable control of emissions, use of state of the art pollution control devices, and minimization of fugitive emissions. The June 17, 2013, submittal makes a subsequent typographical correction to Section V.

The August 8, 2014, submittal makes the following changes: (1) Removes a PM emissions limit at Section III—Kraft Pulp and Paper Manufacturing; (2) revises the frequency required for reporting excess emissions at Section XI—Total Reduced Sulfur Emissions of Kraft Pulp Mills; (3) removes the periodic testing requirement for TRS at Section XII—Periodic Testing; and (4) makes administrative and clarifying edits throughout Standard No. 4. At Section III, the submittal removes the table column “Maximum Allowable Emissions of PM in pounds/equivalent Ton of Air Dried, Unbleached Pulp Produced” and retains the “Maximum Allowable Stack Opacity.” SC DEHC asserts that this will not result in a relaxation of emission limits because the subject sources are covered under more stringent PM limits under the NESHAP (subpart S—National Emission Standards for Hazardous Air Pollutants from the Pulp and Paper Industry). Additionally, the word “opacity” replaces “rate of emissions.”

At Section XI, the August 8, 2014, submittal changes the required excess emissions reporting frequency in subparagraph D.3. from quarterly to semi-annual. SC DHEC considered CAA sections 110(l) and 193 in making the change and asserts changing reporting from quarterly to semi-annual will not affect the level of emissions or compromise the national ambient air quality standards. SC DHEC cites to several Federal and state regulations that address excess emissions reporting, including NSPS subpart BB Standards of Performance for Kraft Pulp Mills; South Carolina Regulation 61-62.5, Standard No. 4 Section XI(D)(3) Total Reduced Sulfur Emissions of Kraft Pulp Mills; South Carolina Regulations 61-62.1, Section II(J)(2) Permit Requirements; and South Carolina Regulation 61-62.70 Title V Operating Permit Program.

At Section XII, the August 8, 2014, submittal removes the periodic testing requirement for TRS. SC DHEC states that most sources are required to test under NSPS or NESHAP rules. The few sources that are not required to test have enough historical test data to develop an allowable operating range which can be handled during the permitting process. Additionally, the S.C. Pollution Control Act (48-1-50, Powers of the Department) makes provision for SC DHEC to ask for a source test and permits are often drafted with language allowing SC DEHC to ask for source tests. Therefore, the requirements will be no less stringent than what is allowed through current regulatory and permitting authority to review testing requirements.

The July 27, 2016, submittal changes Section VIII—Other Manufacturing by excluding Kraft Pulp and Paper Manufacturing facilities. This Section sets PM emission limits for source categories not specified elsewhere in Standard No. 4. The change to exclude Kraft Pulp and Paper Manufacturing facilities aligns with the August 8, 2014, revision, as previously discussed in this notice. The submittal also makes minor typographical, renumbering, and clarifying edits to Section XII—Periodic Testing.

EPA has reviewed the aforementioned changes to South Carolina's Regulation 61-62.5, Standard No. 4 and is approving the revisions into the SIP pursuant to CAA section 110, and where applicable CAA section 193.

III. Response to Comments

EPA previously proposed to approve these changes, and others, to the South Carolina SIP on August 16, 2017 (82 FR 38874) along with a direct final rule published the same date (82 FR 38828). The proposed rule stated that if EPA received adverse comment on the direct final rule, the direct final rule would be withdrawn and all public comments received would be addressed in a subsequent final rule based on the proposed rule. EPA received one adverse comment from a Commenter regarding the portion of the SIP submittals that EPA is addressing in this action, specifically regarding revision of Regulation 61-62.5, Standard No. 4—Emissions from Process Industries, Section IV—Portland Cement Manufacturing. EPA accordingly withdrew those portions of the direct final rule on October 13, 2017 (82 FR 47640).5 EPA has considered the adverse comment received and is now approving the change to Regulation 61-62.5, Section IV.

5 The Commenter also made a comment on Regulation 61-62.5, Standard No. 1—Emissions From Fuel Burning Operations, subparagraph C of Section I—Visible Emissions. EPA will address that in a separate action.

Comment: The Commenter states EPA needs to ensure that no mothballed facilities would be able to restart under the new standard. The Commenter also states that mothballed facilities may still maintain operating permits and may restart under these permits without becoming new sources and subject to NSPS requirements.

Response: EPA notes that operating permits are not issued in perpetuity. A source must renew the permit to continue operations and is required to operate within the emissions limitations established in the permit. If operations resume at a source that has ceased operations for more than two 6 years, that source is subject to new source requirements, regardless of whether that source had previously indicated that it would cease operations permanently. Additionally, SC DHEC provided a letter on February 22, 2018,7 stating there are no mothballed sources below the 120 tons per hour level anywhere in the State.

6 U.S. EPA Applicability Determination Index for NSPS on August 29, 1990, for Florida Portland Cement. Document is available in the Docket.

7 Letter is located in the Federal Docket.

IV. Incorporation by Reference

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of South Carolina Regulation 61-62.5, Standard No. 1 Section I—Visible Emissions, Section II—Particulate Matter Emissions,Section III—Sulfur Dioxide Emissions, Section VI—Periodic Testing, state effective June 27, 2014, and Section IV—Opacity Monitoring Requirements state effective September 23, 2016, which makes administrative and clarifying changes for consistency, removes log reporting requirements, revises monitoring requirements, and Regulation 61-62.5, Standard No. 4 Section II—Sulfuric Acid Manufacturing, Section III—Kraft Pulp and Paper Manufacturing, Section V—Cotton Gins, Section XI—Total Reduced Sulfur Emissions of Kraft Pulp Mills state effective June 27, 2014, and Section VIII—Other Manufacturing, Section XII—Periodic Testing state effective June 24, 2016, which makes administrative and clarifying changes for consistency, removes specific emission rates, and reporting requirements. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated in the next update to the SIP compilation.8

8 62 FR 27968 (May 22, 1997).

V. Final Action

This is a final action based on the proposed rule (82 FR 38874). For the reasons discussed above, EPA is approving the aforementioned changes to the South Carolina SIP, submitted on October 1, 2007, July 18, 2011, June 17, 2013, August 8, 2014, July 27, 2016, and November 4, 2016, because they are consistent with the CAA and federal regulations.

VI. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. These actions merely approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, these actions:

• Are not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Are not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Are not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Are not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Are not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this final action for the State of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have substantial direct effects on an Indian Tribe. The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 24, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

The Environmental Protection Agency (EPA) is finalizing its action to codify into the Code of Federal Regulations (CFR) the delegation of authority to implement and enforce the Federal Plan Requirements for Sewage Sludge Incineration Units Constructed on or before October 14, 2010 (SSI Federal Plan) to the New Hampshire Department of Environmental Services (NH DES). The SSI Federal Plan addresses the implementation and enforcement of the emission guidelines applicable to existing SSI units located in areas not covered by an approved and currently effective state plan. The SSI Federal Plan imposes emission limits and other control requirements for existing affected SSI facilities which will reduce designated pollutants. This action is being taken under the Clean Air Act (CAA).

DATES:

This rule is effective on July 25, 2018.

ADDRESSES:

EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2018-0069. All documents in the docket are listed on the https://www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Quality Planning Unit, 5 Post Office Square—Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

Table of ContentsI. What action is the EPA taking today?II. What was submitted by the NH DES and how did the EPA respond?III. What comments were received in response to the EPA's proposed action?IV. What is the EPA's conclusion?V. Statutory and Executive Order ReviewsI. What action is the EPA taking today?

The EPA is finalizing through codification of regulatory text in 40 CFR part 62, subpart EE the delegation of authority to implement and enforce the SSI Federal Plan to the NH DES. A Memorandum of Agreement (MoA), which became effective on December 22, 2017, serves as the transfer mechanism for the implementation and enforcement authority to NH DES. However, nothing in this action, nor in the MoA, shall be construed to prohibit the EPA from enforcing the SSI Federal Plan.

II. What was submitted by the NH DES and how did the EPA respond?

On November 14, 2017, the NH DES submitted to the EPA a request for delegation of authority from the EPA to implement and enforce the SSI Federal Plan. The EPA prepared the MoA that defined the policies, responsibilities, and procedures by which the SSI Federal Plan would be administered by both the NH DES and the EPA, pursuant to 40 CFR part 62, subpart LLL for SSI units. Condition I.E. of the MoA states, “The delegation of the Federal Plan to New Hampshire shall become effective upon authorized signature of both the NH DES and the EPA.” 1 On December 18, 2017, Mr. Robert R. Scott, Commissioner of NH DES signed the MoA, and on December 22, 2017, Mr. Ken Moraff, as Acting Regional Administrator of EPA Region 1 signed the MoA. The MoA became effective upon signature by Mr. Ken Moraff on December 22, 2017.

1 See the Memorandum of Agreement Between New Hampshire Department of Environmental Services and The United States Environmental Protection Agency, Region 1 Sewage Sludge Incinerators Federal Plan Delegation. The reader may refer to it in the docket for this rulemaking at www.regulations.gov (see Docket ID Number EPA-R01-OAR-2018-0069).

III. What comments were received in response to the EPA's proposed action?

The EPA published a proposed rulemaking concerning this action on March 16, 2018. See 83 FR 11652. In response to the EPA's March 16, 2018 proposed rulemaking action, we received a number of anonymous comments on the proposed action that were not germane to the proposal and/or did not specify what changes should be made to the NH DES delegation of the SSI Federal Plan. Many of the comments identified and pertained to issues that are outside the scope of, and do not reference, the proposed action. Therefore, EPA will not provide any further specific responses to these comments.

EPA did however receive one comment which could be construed to refer to the proposed rulemaking for the NH DES SSI Federal Plan delegation.

Comment: A single anonymous comment, much of which included information that was not germane to EPA's proposed rulemaking for the NH DES SSI Federal Plan delegation, also stated that “The Rule created potentially unduly burdensome requirements [sic] Given the extremely limited pollutant loadings and relative high costs, according to EPA's own analysis, these requirements appear to be ripe for substantial reduction or elimination. this [sic] entire subcategory would be excluded by rule given the de minimis amount of pollution.”

Response: If “The Rule” in the submitted comment refers to EPA's March 16, 2018 (83 FR 11652) proposed rulemaking, EPA disagrees with the comment because this action merely codifies the delegation of an existing Federal requirement to the State and does not impose additional requirements beyond those imposed by existing Federal regulations.

IV. What is the EPA's conclusion?

For the reasons described above and in EPA's proposal, the EPA is finalizing its action to codify into the CFR the delegation of authority to implement and enforce the SSI Federal Plan to NH DES. EPA will codify the delegation and reference to the MoA at 40 CFR part 62 subpart EE, thus satisfying the procedural requirements outlined in EPA's Delegation Manual.2

2 Section 7-139 of the EPA's Delegation Manual is entitled “Implementation and Enforcement of 111(d)(2) and 111(d)/129(b)(3) Federal Plans” and the reader may refer to it in the docket for this rulemaking at www.regulations.gov (see Docket ID Number EPA-R01-OAR-2018-0069).

V. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a state plan submission that complies with the provisions of the CAA section 111(d) and 129(b)(2) and applicable Federal regulations. 42 U.S.C. 7411(d) and 7429(b)(2); 40 CFR 62.02(a). Thus, in reviewing state plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves a state delegation request as meeting Federal requirements and does not impose additional requirements beyond those already imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rulemaking does not apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

(a) Letter from the New Hampshire Department of Environmental Services (NH DES), submitted November 14, 2017, requested delegation of authority from the EPA to implement and enforce the Federal Plan Requirements for Sewage Sludge Incineration Units Constructed on or before October 14, 2010 (SSI Federal Plan). The SSI Federal Plan will be administered by both the NH DES and the EPA pursuant to 40 CFR part 62 subpart LLL.

(b) Identification of sources. The SSI Federal Plan applies to owners or operators of existing facilities that meet all three of the following criteria:

(1) The SSI unit(s) commenced construction on or before October 14, 2010;

(2) The SSI unit(s) meets the definition of an SSI unit as defined in § 62.16045; and

(3) The SSI unit(s) is not exempt under § 62.15860.

(c) On December 18, 2017 Mr. Robert R. Scott, Commissioner of NH DES, signed the Memorandum of Agreement (MoA) which defines the policies, responsibilities, and procedures by which the SSI Federal Plan will be administered. On December 22, 2017, Mr. Ken Moraff, as Acting Regional Administrator of EPA Region 1, signed the MoA.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; extension of opening date.

SUMMARY:

NMFS is extending the opening date of the subsistence use season of the Eastern Pacific stock of northern fur seals (Callorhinus ursinus) by opening the season on June 20, 2018, in response to a request from the Traditional Council of St. George Island, Tribal Government. The subsistence use regulations at 50 CFR 216.72(a) authorize the extension of the northern fur seal harvest earlier than the scheduled opening date of June 23. The opening of the season three days earlier is intended to provide meat for the community of St. George Island in response to the unavailability of food in the community store due to unforeseen flight cancellations and the complete consumption of fur seal meat from harvests in 2017.

DATES:

The opening for the sub-adult male fur seal harvest is effective at 12:01 a.m., Alaska local time, June 20, 2018, until 11:59 p.m., Alaska local time, August 8, 2018, per the regulations at 50 CFR 216.72(d)(1).

St. George Island is a remote island located in the Bering Sea populated by Alaska Native residents who rely upon marine mammals as a major food source and cornerstone of their culture. Regulations issued under the authority of the Fur Seal Act authorize Pribilovians to take fur seals on the Pribilof Islands if such taking is for subsistence uses and not accomplished in a wasteful manner (50 CFR 216.71).

The residents of St. George Island are currently authorized by regulations under the FSA Section 105 (16 U.S.C. 1155) to harvest male fur seals 124.5 centimeters or less in length for subsistence use each year from June 23 to August 8. The regulation at 50 CFR 216.72(a) includes the provision that the harvests of seals on St. Paul and St. George Islands shall be treated independently for the purposes of this section. Any suspension, termination, or extension of the harvest is applicable only to the island for which it is issued. The Traditional Council of St. George Island, Tribal Government (Traditional Council) has requested that NMFS extend the opening date of the subsistence use season for sub-adult male fur seals earlier than the scheduled opening date of June 23 (50 CFR 216.72(d)(1)). The extension of the opening date is intended to respond to this emergency request. The extension will ensure additional days to conduct the subsistence harvest in order provide meat for the community of St. George Island in response to the unavailability of food in the community store due to unforeseen flight cancellations and the complete consumption of fur seal meat from harvests in 2017. NMFS has determined that the extension of the harvest to an earlier date is permissible and should be authorized.

On July 31, 1992 (57 FR 33900) NMFS issued a final rule removing the option to extend the harvest past August 8, but authorized the harvest to start on June 23 rather than June 30. NMFS anticipated in the notice (57 FR 33901, July 31, 1992) that there would be no adverse impacts on the population from an earlier June harvest because sub-adult males dominate the harvest areas on the hauling grounds at this time of year, and few if any female seals have returned to St. George Island in June. In extending the opening date for the 2018 season, NMFS does not expect that female fur seals would be accidentally killed during the few early days of the sub-adult male harvest, and there is no evidence from prior commercial or subsistence harvests that females were accidentally taken prior to mid-July (NMFS unpublished data). The subsistence use suspension and termination provisions based on female mortality remain in effect (50 CFR 216.72(f)(1)(iv) & (g)(3)).

All other regulatory controls applicable to the subsistence use of sub-adult males on St. George Island at 50 CFR 216.72(d)(1)-(5) still apply, including the total number of fur seals (500) that may be harvested per year on St. George Island (82 FR 39044, August 17, 2017).

Classification

This action responds to the urgent subsistence need of the Pribilovians on St. George Island. The Assistant Administrator for Fisheries, NOAA, (AA), determined that this rule is consistent with the Fur Seal Act (16 U.S.C. 1155) and regulations (50 CFR 216.71-216.74). The AA finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B). Allowing prior notice and opportunity for public comment on the extension of the opening date is unnecessary because the rule establishing the extension of the opening procedures has already been subject to notice and comment, and all that remains is to notify the public of the extension of the opening date. Additionally, allowing for prior notice and opportunity for public comment for this extension of the opening date is contrary to the public interest because it requires time, thus delaying the removal of a restriction and thereby reducing socio-economic benefits to community of St. George Island. In the absence of this action, the residents of St. George Island would be prohibited from harvesting fur seals currently necessary to subsistence uses due to unforeseen events prior to the scheduled opening of the subsistence use season. For the aforementioned reasons, it is impracticable and contrary to the public interest to delay for 30 days the effective date of this action, and, accordingly, the AA also finds good cause to waive the 30-day delay in effectiveness of this action under 5 U.S.C. 553(d)(3) and to make this action effective on the date specified herein. This action is authorized by 50 CFR 216.72(a) and is exempt from review under Executive Order 12866. Because prior notice and opportunity for public comment are waived under 5 U.S.C. 553, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601-612, are inapplicable.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Final rule.

SUMMARY:

NMFS issues this rule to implement annual management measures and catch limits for the northern subpopulation of Pacific sardine, for the fishing year lasting from July 1, 2018, through June 30, 2019. This action includes a prohibition on directed commercial fishing for Pacific sardine off the U.S. West Coast, except in the live bait, tribal, or minor directed fisheries. This action is intended to conserve and manage the Pacific sardine stock off the U.S. West Coast.

NMFS manages the Pacific sardine fishery in the U.S. exclusive economic zone (EEZ) off the West Coast (California, Oregon, and Washington) in accordance with the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP). The FMP and its implementing regulations require NMFS to set annual catch levels for the Pacific sardine fishery based on the annual specification framework and control rules in the FMP. These control rules include the harvest guideline (HG) control rule, which, in conjunction with the overfishing limit (OFL) and acceptable biological catch (ABC) rules in the FMP, are used to manage harvest levels for Pacific sardine, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Annual specifications published in the Federal Register establish these catch limits and management measures for each Pacific sardine fishing year.

The purpose of this final rule is to implement the annual catch levels and reference points for the 2018-2019 fishing year. This final rule adopts, without changes, the catch levels and restrictions that NMFS proposed in the rule published on May 25, 2018 (83 FR 24269), including the OFL and ABC that takes into consideration uncertainty surrounding the current estimate of biomass for Pacific sardine in the U.S. EEZ off the U.S. West Coast. The proposed rule for this action included additional background on specifications and the details of how the Pacific Fishery Management Council (Council) derived its recommended specifications for Pacific sardine. Those details are not repeated here. For additional information, please refer to the proposed rule for this action.

This final rule implements an OFL of 11,324 metric tons (mt), an ABC of 9,436 mt, and a prohibition on Pacific sardine catch, unless it is harvested as part of the live bait, tribal, or minor directed fisheries, or as incidental catch in other fisheries (Table 1). Additionally, this rule implements an ACL of 7,000 mt, as well as restrictions on the incidental catch of Pacific sardine by other fisheries.

The incidental catch of Pacific sardine in other CPS fisheries will be managed with the following automatic inseason actions to reduce the potential for both targeting and discard of Pacific sardine in these fisheries:

• An incidental per landing by weight allowance of 40 percent Pacific sardine in non-treaty CPS fisheries until a total of 2,500 mt of Pacific sardine has been landed; and

• A reduction of the incidental per landing allowance to 20 percent for the remainder of the 2018-2019 fishing year once 2,500 mt Pacific sardine has been landed.

Pacific sardine is known to comingle with other CPS stocks; thus, these incidental allowances are established to allow for the continued prosecution of these other important CPS fisheries and reduce the potential discard of sardine. Additionally, this final rule implements an incidental per landing allowance of up to 2 mt per trip in non-CPS fisheries.

The NMFS West Coast Regional Administrator will publish a notice in the Federal Register to announce when catch reaches the incidental limits as well as any changes to allowable incidental catch percentages. Additionally, to ensure that the regulated community is informed of any closure, NMFS will make announcements through other means available, including fax, email, and mail to fishermen, processors, and state fishery management agencies.

As explained in the proposed rule, the Quinault Indian Nation requested a set-aside for tribal harvest of 800 mt (the same amount that was requested and approved for the 2017-2018 fishing season). Consistent with this request, NMFS is setting aside 800 mt of the 2018-2019 ACL for tribal harvest (Table 1).

At the April 2018 meeting, the Council voted in support of two exempted fishing permit (EFP) proposals requesting an exemption from the prohibition to directly harvest Pacific sardine. The ACL implemented in this action accounts for the potential of NMFS approval of up to 610 mt of the ACL to be harvested for EFP activities.

Comments and Responses

On May 25, 2018, NMFS published a proposed rule for this action and solicited public comments (83 FR 24269), with a public comment period that ended on June 11, 2018. NMFS received one comment letter from the environmental advocacy organization Oceana during the comment period. After consideration of the public comment, no changes were made from the proposed rule. NMFS summarizes and responds to the comment letter below.

Comment 1: Oceana supported the prohibition on non-tribal directed commercial sardine fishing, but opposed the proposed ACL level of 7,000 mt. Oceana instead requested that NMFS set an ACL of no more than 2,000 mt. Oceana commented that the proposed ACL of 7,000 mt is excessive and not commensurate with the decline in sardine biomass and that NMFS should reduce the ACL to 2,000 mt.

Response: NMFS disagrees that it is necessary to set the ACL lower than 7,000 mt. The ACL should be viewed in the context of the approved northern subpopulation of Pacific Sardine OFL (11,324 mt) and ABC (9,436 mt), which has been reduced from the OFL to account for scientific uncertainty. The Council's SSC endorsed the OFL and ABC, which are derived from control rules in the FMP, as the best scientific information available. The CPS FMP defines overfishing as catch exceeding the OFL. By definition, if catch approaches either the ACL or ABC, which are set below the OFL, overfishing would not be occurring. This rule conservatively limits harvest levels by all sources with an ACL of 7,000 mt, which is below both the OFL and ABC. All incidental catch, live bait, minor directed, and tribal harvest of sardine are managed to stay at or below the ACL. Additionally, as a direct result of the decline in the estimated biomass from the last fishing year, the OFL and ABC implemented through this action are respectively approximately 33 and 40 percent lower than those implemented last year.

Small pelagic species, such as sardine, undergo wide natural fluctuations in abundance related to environmental conditions, even in the absence of fishing pressure. Given that environmental conditions are a strong driver for small pelagic species biomass, and the fact that 7,000 mt is only about 13 percent of the 2018 biomass estimate, it is highly unlikely that reducing the ACL from 7,000 mt to 2,000 mt would measurably contribute to the potential for Pacific sardine abundance to increase. Even in the absence of any fishing mortality, unfavorable environmental conditions could keep the sardine population at a low level. Based on the recent stock assessments and NMFS research, low recent recruitment (i.e., the number of young fish maturing into the spawning population) is the primary cause of the current downward trend in overall population size. Research suggests recruitment is strongly related to environmental conditions, particularly large-scale oceanographic phenomena.

Comment 2: Oceana also commented that the OFL is not based on the best scientific information available because Oceana construes new research from NMFS Southwest Fisheries Science Center (SWFSC) as demonstrating that the temperature-recruitment relationship based on data from the California Cooperative Oceanic Fisheries Investigations (CalCOFI) survey used to inform the OFL is no longer applicable.

Response: NMFS is committed to using the best scientific information available, and the SWFSC is continuing research to improve our understanding of the relationship between Pacific Sardine productivity and environmental conditions. The new research referenced by Oceana is still under development, has not been formally reviewed, and therefore is not yet a valid rationale to cease using CalCOFI data to gauge the temperature-recruitment relationship. At this time, the CalCOFI-based temperature relationship is still the best scientific information available science to set the OFL.

Comment 3: In addition to commenting on the proposed rule, Oceana's comment requested reconsideration of various aspects of sardine management that are not considered in this action, including changing the start date of the fishery, revision of the Minimum Stock Size Threshold value, and various modifications to the OFL, ABC and HG control rules.

Response: Changes to the management framework of Pacific sardine and to the sardine harvest control rules are set in the CPS FMP and are beyond the scope of this rulemaking. NMFS will take these comments into consideration during related future management planning for the Pacific sardine stock, and recommends Oceana continue to bring these concerns to the attention of the Council as that body deliberates about the management framework for sardine.

Classification

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the CPS FMP, other provisions of the Magnuson-Stevens Act, and other applicable law. There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness of these final harvest specifications for the 2018-2019 Pacific sardine fishing season. In accordance with the FMP, this rule was recommended by the Council at its meeting in April 2018 the contents of which were based on the best available new information on the population status of Pacific sardine that became available at that time. Making these final specifications effective on July 1, the first day of the fishing season, is necessary for the conservation and management of the Pacific sardine resource because last year's restrictions on harvest are not effective after June 30. The FMP requires a prohibition on directed fishing for Pacific sardine for the 2018-2019 fishing year because the sardine biomass has dropped below the CUTOFF. The purpose of the CUTOFF in the FMP, and for prohibiting a directed fishing when the biomass drops below this level, is to protect the stock when biomass is low and provide a buffer of spawning stock that is protected from fishing and can contribute to rebuilding the stock. A delay in the effectiveness of this rule for a full 30 days would result in the re-opening the directed commercial fishery on July 1.

Delaying the effective date of this rule beyond July 1 would be contrary to the public interest because it would jeopardize the sustainability of the Pacific sardine stock. Furthermore, most affected fishermen are aware that the Council recommended that directed commercial fishing be prohibited for the 2018-2019 fishing year and are fully prepared to comply with the prohibition.

This final rule is exempt from the procedures of E.O. 12866 because this action contains no implementing regulations.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

Pursuant to Executive Order 13175, this final rule was developed after meaningful consultation and collaboration with the tribal representative on the Council who has agreed with the provisions that apply to tribal vessels.

This action does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Temporary rule; closure.

SUMMARY:

NMFS is prohibiting directed fishing for Kamchatka flounder in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2018 Kamchatka flounder initial total allowable catch (ITAC) in the BSAI.

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2018 Kamchatka flounder ITAC in the BSAI is 4,250 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish in the BSAI (83 FR 8365, February 27, 2018). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 Kamchatka flounder ITAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,000 mt, and is setting aside the remaining 2,250 mt as incidental catch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Kamchatka flounder in the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

Classification

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Kamchatka flounder to directed fishing in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of June 18, 2018.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

We are proposing to amend the Phytophthora ramorum regulations to remove regulated areas for P. ramorum from the regulations, as well as all regulatory requirements specific to such areas. We are proposing to amend the regulations by revising the inspection and sampling requirements for certain nurseries that are in areas quarantined for P. ramorum and that ship regulated nursery stock interstate. We are proposing to change the nature of the inspection and sampling requirements to have them take into consideration additional potential sources of P. ramorum inoculum at the nurseries. Finally, we are proposing to establish conditions under which we would regulate nurseries located outside of the quarantined areas for P. ramorum, if sources of P. ramorum inoculum are detected at those nurseries and the nurseries ship certain articles interstate. These changes would provide regulatory relief to nurseries in areas that are regulated for P. ramorum, while also ensuring that nurseries that may pose a risk of disseminating P. ramorum through the interstate movement of regulated nursery stock are subject to measures that address this risk.

DATES:

We will consider all comments that we receive on or before August 24, 2018.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0101 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW, Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

Under section 412(a) of the Plant Protection Act (7 U.S.C. 7701 et seq., referred to below as the PPA), the Secretary of Agriculture may prohibit or restrict the movement in interstate commerce of any plant or plant product, if the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of a plant pest within the United States.

Phytophthora ramorum, commonly known as sudden oak death, ramorum leaf blight, and ramorum dieback, is a harmful pathogen that can cause mortality in several oak tree species and also causes twig and foliar diseases in numerous native and non-native ornamental plants, shrubs, and trees within the United States.

P. ramorum was first discovered in the natural environment in 14 counties in California and portions of 1 county in Oregon. When the disease was subsequently discovered in certain nurseries on the west coast that shipped nursery stock interstate, the Animal and Plant Health Inspection Service (APHIS) issued an interim rule published in the Federal Register on February 14, 2002 (67 FR 6827-6837, Docket No. 01-054-1). The interim rule established a new subpart, “Subpart—Phytophthora ramorum” (7 CFR 301.92 through 301.92-12, referred to below as the regulations), which contains APHIS' regulations to address the spread of P. ramorum.

Section 301.92-3 of the regulations designates certain States and portions of States as quarantined areas for P. ramorum. The regulations also designate other States or portions of States as regulated areas for P. ramorum. Quarantined areas are areas in which P. ramorum has been confirmed by an inspector to exist in the natural environment, in which there is reason to believe P. ramorum exists in the natural environment, or which APHIS considers to be inseparable for quarantine enforcement purposes from localities in which P. ramorum has been found in the natural environment.

Regulated areas are defined in the regulations as areas in which P. ramorum has been found on nursery stock in commercial nurseries, but in which P. ramorum has not been found in the natural environment. The quarantined areas for P. ramorum are designated in paragraph (a) of § 301.92-3. Regulated areas for P. ramorum are designated in paragraph (b) of § 301.92-3. Quarantined areas include 14 counties in California and a portion of 1 county in Oregon. Regulated areas include the remainder of California and Oregon, as well as the State of Washington.

Section 301.92-2 of the regulations designates nursery stock of proven host taxa for P. ramorum as regulated articles for P. ramorum. It also designates nursery stock of taxa associated with P. ramorum, but not proven to be hosts, as associated articles for P. ramorum. Nursery stock of taxa that are neither designated as proven hosts nor as associated with P. ramorum are considered to be non-hosts.

Section 301.92-4 of the regulations contains conditions for the interstate movement of regulated and non-host nursery stock from quarantined areas for P. ramorum. This section also contains conditions for the interstate movement of regulated and non-host nursery stock from regulated areas for P. ramorum. The conditions for movement of both regulated and non-host nursery stock from a quarantined area for P. ramorum are found in paragraphs (a) and (c) of § 301.92-4, while the conditions for interstate movement of both regulated and non-host nursery stock from a regulated area for P. ramorum are found in paragraph (d) of that section.

Paragraph (d) requires certificates to be issued in order for regulated nursery stock to be shipped interstate from a regulated area for P. ramorum, and also requires certificates to be issued for the interstate movement of non-host nursery stock, if the nursery from which the nursery stock originates contains regulated or associated articles for P. ramorum. If the nursery contained only non-host nursery stock, then certificates are not required, provided that the nursery is inspected and found free of evidence of P. ramorum. (We discuss the inspection protocols, which are found in § 301.92-11 of the regulations, in the following paragraphs.)

Section 301.92-5 of the regulations requires that, in order for nurseries in quarantined or regulated areas for P. ramorum to ship regulated or non-host nursery stock interstate under a certificate, the nurseries have to be inspected annually in accordance with inspection and sampling protocols. The inspection and sampling protocols are found in § 301.92-11 of the regulations. The inspection and sampling protocols for nurseries in quarantined areas for P. ramorum that ship regulated or non-host nursery stock interstate are found in paragraphs (a) and (b) of § 301.92-11, respectively, while the inspection and sampling protocols for nurseries in regulated areas for P. ramorum that ship regulated or non-host nursery stock interstate are found in paragraphs (c) and (d) of § 301.92-11, respectively.

Paragraph (c) of § 301.92-11 contains the following inspection and sampling protocol for nurseries in regulated areas for P. ramorum that ship regulated nursery stock interstate: Visual inspection of the nurseries for symptoms of P. ramorum; sampling of plants showing symptoms of infection with P. ramorum; and testing of those samples using an approved test (approved tests and testing protocols for P. ramorum are found in § 301.92-12 of the regulations). While testing is ongoing, the symptomatic plants, the lot containing the symptomatic plants, and plants located within 2 meters of that lot cannot be moved interstate. Nurseries in quarantined areas for P. ramorum are subject to a similar protocol with more stringent inspection requirements. Finally, nurseries in quarantined and regulated areas for P. ramorum that contain and ship only non-host nursery stock are subject to a similar inspection protocol, but are only subject to sampling and testing if an inspector found plants showing symptoms of P. ramorum.

Over a 9-year period, from 2004, when we implemented these protocols, to 2013, APHIS and the State plant protection authorities of California, Oregon, and Washington inspected approximately 3,050 nurseries annually. During that time period, P. ramorum was never detected at a nursery located in a regulated area for P. ramorum and that contains and ships interstate only non-host nursery stock. Additionally, P. ramorum was discovered in the natural environment of only one area that had been regulated for P. ramorum, a portion of Curry County, OR.

Additionally, of the nurseries in regulated areas for P. ramorum that contain and ship interstate regulated nursery stock, P. ramorum was detected at a very small percentage—usually no more than 3 percent annually. The vast majority of the nurseries were found free of P. ramorum each time they were inspected.

If P. ramorum was detected at a nursery during one of these inspections, however, it often was not limited to infected plants. Rather, multiple sources of the inoculum often were detected at the nursery; these include growing media, pots used for nursery stock, standing water, drainage water, and water used for irrigation. This is also true of nurseries that are located in quarantined areas for P. ramorum and in which the disease was detected.

Finally, between 2004 and 2013, APHIS detected P. ramorum in 120 nurseries in areas that are neither quarantined nor regulated for P. ramorum, and in which APHIS has no reason to believe P. ramorum exists in the natural environment. Most of these nurseries were retailers that sell directly to consumers and do not engage in interstate commerce. However, some did ship regulated, restricted, and associated articles interstate. Several of those nurseries tested positive for P. ramorum in their soil, standing water, water for irrigation, or growing media.

This data led us to reevaluate our regulatory strategy for addressing the artificial spread of P. ramorum within the United States. As a result of this reevaluation, we no longer saw a need for regulating geographical areas for P. ramorum unless we determined that the area met the criteria for designation as a quarantined area for P. ramorum. However, we did see a need to regulate nurseries outside of quarantined areas for P. ramorum if the nurseries shipped regulated, restricted, or associated articles interstate and sources of P. ramorum were discovered at the nursery.

Accordingly, in a Federal Order issued on January 10, 2014, and a Federal Order issued on April 3, 2015, we restructured the domestic quarantine program for Phytophthora ramorum.1 Specifically:

• We deregulated all regulated areas for P. ramorum, and removed all regulatory restrictions specific to those areas.

• Instead of regulated areas for P. ramorum, we implemented regulated establishments for P. ramorum. A regulated establishment is a nursery that is not located in a quarantined area for P. ramorum, that ships regulated, restricted, or associated articles interstate, and in which sources of P. ramorum inoculum are detected on nursery stock, or in soil, growing media, pots used for nursery stock, standing water, drainage water, water used for irrigation, or any other regulated, restricted, or associated articles at the nursery.

• We instituted inspection and sampling protocols for regulated establishments.

• We implemented restrictions on the interstate movement of regulated, restricted, and associated articles from regulated establishments.

• We revised the inspection and sampling protocol for nurseries in quarantined areas, as well as the conditions for interstate movement of regulated, restricted, and associated articles from certain of those nurseries.

We are proposing to update the regulations to reflect the changes made by the Federal Orders to the Phytophthora ramorum domestic quarantine program. Additionally, we are proposing to update the lists of regulated and associated articles for P. ramorum, and establish conditions for the interstate movement of soil samples from areas quarantined for P. ramorum.

Below, we discuss these amendments to the regulations at greater length.

Removal of Regulated Areas and Establishment of Regulated Establishments

As we mentioned earlier in this document, paragraph (b) of § 301.92-3 lists areas designated as regulated areas for Phytophthora ramorum. Proposed paragraph (b) would provide conditions for the designation and deregulation of regulated establishments. Specifically, it would state that the Administrator would designate a nursery that is not located in a quarantined area for P. ramorum as a regulated establishment for P. ramorum if the nursery ships regulated, restricted, or associated articles interstate and sources of P. ramorum are detected on nursery stock, or in soil, growing media, pots used for nursery stock, standing water, drainage water, water used for irrigation, or any other regulated, restricted, or associated articles at the nursery. It would also state that the Administrator would withdraw regulation of a regulated establishment if, for 3 consecutive years, each time the nursery is inspected by an inspector, it is found free of sources of P. ramorum inoculum. We discuss the inspection and sampling protocols for regulated establishments later in this document.

Currently, paragraph (d) of § 301.92-4 contains conditions for interstate movement of both regulated and non-host nursery stock from a regulated area for Phytophthora ramorum. Proposed paragraph (d) would contain conditions for the movement of regulated, restricted, and associated articles from regulated establishments. In order for such articles to be moved interstate, the regulated establishment would have to enter into a compliance agreement with APHIS, and the articles would have to be accompanied by a certificate issued in accordance with § 301.92-5. We are also proposing to amend the heading of the section so that it is clear that it contains conditions for the interstate movement of regulated, restricted, and associated articles from regulated establishments.

Within § 301.92-5, paragraph (b) contains conditions for the issuance of certificates for regulated articles of nursery stock, associated articles, and non-host nursery stock from nurseries in regulated areas. Proposed paragraph (b) would contain conditions for the issuance of certificates for regulated, restricted, and/or associated articles from regulated establishments. Under the proposal, in order for a certificate to be issued for such articles, an inspector would have to determine that the nursery entered into a compliance agreement with APHIS and abided by all terms and conditions of that compliance agreement, the nursery had been inspected in accordance with the inspection and sampling protocols specified in § 301.92-11, the articles to be shipped interstate are free from P. ramorum inoculum, and the movement of the articles would not be subject to additional restriction under the PPA or other Federal domestic plant quarantines and regulations.

Specifically, proposed paragraph (c) would require that regulated establishments be inspected at least twice annually for symptoms of P. ramorum infestation by an inspector. The inspection would focus on regulated plants and other potential sources of P. ramorum inoculum. Additionally, during such inspections, samples would be taken from host plants, soil, standing water, drainage water, water for irrigation, growing media, and any other articles determined by the inspector to be possible sources of P. ramorum inoculum. The number of samples taken could vary depending on the possible sources of P. ramorum identified at the nursery, as well as the number of host articles in the nursery. Finally, samples would be labeled and sent for testing to a laboratory approved by APHIS in accordance with the regulations.

If all samples tested returned negative results for P. ramorum, an inspector could certify that the nursery is free of P. ramorum at the time of the inspection, and all regulated, restricted, and associated articles at the nursery would be considered free from P. ramorum inoculum for purposes of § 301.92-5(b) until the time of the next inspection. Additionally, as we mentioned previously in this document, if, for 3 consecutive years, the nursery is determined to be free of sources of P. ramorum inoculum each time it is inspected by an inspector, it would be deregulated.

If any samples tested return positive results for P. ramorum, the nursery could ship lots of regulated, restricted, or associated articles interstate under a certificate only if the lot is determined to be free from P. ramorum inoculum. (In other words, the articles at the nursery are not presumed to be free from P. ramorum inoculum because of the positive samples, and would be evaluated on a lot-by-lot basis.) The method for this determination would be specified within the nursery's compliance agreement with APHIS.

Paragraph (d) of § 301.92-11 contains an inspection and sampling protocol for nurseries in regulated areas for P. ramorum that ship non-host nursery stock interstate, and do not contain regulated or associated articles. Because we are proposing to remove regulated areas from the regulations, and nurseries that only contain and ship interstate non-host nursery stock would not be designated as regulated establishments, we are proposing to remove the inspection and sampling protocol contained in paragraph (d) of § 301.92-11 from the regulations.

We are also proposing to make several harmonizing changes to other sections of the regulations to reflect the removal of regulated areas for P. ramorum and implementation of regulated establishments for P. ramorum.

Section 301.92 contains general restrictions on the interstate movement of regulated, restricted, and associated articles, as well as other nursery stock. Paragraph (b) of § 301.92 states that no person may move nursery stock interstate from a nursery in a regulated area for P. ramorum except in accordance with the regulations. Proposed paragraph (b) would specify that no person may move restricted, regulated, or associated articles from a regulated establishment except in accordance with the regulations.

Currently, paragraph (c) of § 301.92 states that no person may move regulated, restricted, or associated articles interstate from a quarantined or regulated area for P. ramorum if the articles have been tested with a test approved by APHIS and found infected with P. ramorum, or if the articles are part of a plant that was found infected with P. ramorum, unless the articles are moved in accordance with 7 CFR part 330 (i.e., our regulations governing the interstate movement of plant pests). Proposed paragraph (c) would prohibit the interstate movement from quarantined areas or regulated establishments of articles that have been found infected with P. ramorum or that are part of a plant that has been found infected with P. ramorum.

Section 301.92-1 contains definitions of terms used in the regulations. The section includes a definition of regulated area. Since that term is no longer used in the P. ramorum domestic quarantine program, we are proposing to remove the definition from § 301.92-1. We are also proposing to add a definition of regulated establishment to § 301.92-1. The definition would state that a regulated establishment is any nursery regulated by APHIS pursuant to paragraph (b) of § 301.92-3 of the regulations.

Revisions to Inspection and Sampling Protocols for Quarantined Areas

As we mentioned earlier in this document, paragraph (a) of § 301.92-11 contains an inspection and sampling protocol for nurseries in quarantined areas for P. ramorum that ship regulated nursery stock interstate, while paragraph (b) of § 301.92-11 contains an inspection and sampling protocol for nurseries in quarantined areas for P. ramorum that ship non-host nursery stock interstate.

Proposed paragraph (a) would contain two separate inspection and sampling protocols. Pursuant to the January 2014 Federal Order, if P. ramorum has not been discovered at the nursery since March 31, 2011, the inspection and sampling protocol for the nursery would be substantially similar to the one currently stated in the regulations. The only change would be the minimum number of samples that would be tested at the nursery: Whereas the regulations provide for a minimum of 40 samples, under the Federal Order the minimum number of samples is set on a nursery-by-nursery basis depending on the amount of regulated, restricted, and associated articles at the nursery. We are proposing to revise paragraph (a) to align the regulations with changes made by the Federal Order.

Proposed paragraph (a) would also provide that if, however, P. ramorum has been discovered at the nursery since March 31, 2011, the nursery would be subject to the same inspection and sampling protocol as that specified for regulated establishments. Unlike regulated establishments, however, if a nursery in a quarantined area is tested and found free of P. ramorum inoculum for 3 consecutive years, it would not be released from regulation, but rather reverted to the previous inspection and sampling protocol.

We are proposing minor revisions to paragraph (b) of § 301.92-11 to reflect these changes to paragraph (a).

We are also proposing to make one additional amendment to § 301.92-11. The introductory text to the section contains a table to aid nurseries in determining what inspection and sampling protocol they are subject to. One of the primary purposes of the table is to delineate the different inspection and sampling protocols for regulated areas, which is no longer necessary. Another primary purpose of the table is to clarify that inspection and sampling protocols for nurseries in quarantined areas differed based on whether the nursery ships regulated nursery stock interstate. This is no longer necessarily the case; a nursery in a quarantined area for P. ramorum that ships only regulated nursery stock interstate would be subject to the same inspection and sampling protocol as a nursery that ships non-host nursery stock interstate if P. ramorum had not been discovered at the nursery since March 31, 2011. For these reasons, we are proposing to remove the table from the regulations.

As we mentioned earlier in this document, § 301.92-12 of the regulations contains approved tests and testing protocols for P. ramorum. Paragraph (a) is written in a manner which considers all samples tested for P. ramorum using an optional ELISA prescreening to be plants or plant products. As a result of our proposed revisions to § 301.92-11, samples tested using an optional ELISA prescreening may not always be from plants or plant products; for example, they may come from standing water or water used for irrigation. Therefore, we are proposing to revise paragraph (a) of § 301.92-12 accordingly.

Revisions to the Lists or Regulated and Associated Articles

As we mentioned previously in this document, § 301.92-2 of the regulations designates nursery stock of proven host taxa for P. ramorum as regulated articles for P. ramorum. It also designates nursery stock of taxa associated with P. ramorum, but not proven to be hosts, as associated articles for P. ramorum. We are proposing to add Cinnamomum camphora and Gaultheria procumbens to the list of regulated articles, and Ilex cornuta, Illicium parviflorum,Larix kaempferi, Magnolia denudata,Mahonia nervosa, Molinadendron sinaloense,Trachelospermum jasminoides, and Veronica spicata Syn. Pseudolysimachion spicatum to the list of associated articles.

Conditions for the Interstate Movement of Soil Samples

As we mentioned previously in this document, paragraph (a) of § 301.92-4 provides conditions for the interstate movement of regulated articles from quarantined areas for P. ramorum. Paragraph (a)(2) of that section provides conditions for the interstate movement of regulated articles without a certificate.

On June 1, 2016, we issued a Federal Order 2 authorizing the interstate movement of soil samples for chemical or physical (compositional analysis) from quarantined areas for P. ramorum without a certificate, provided that they are moved to a laboratory, and that laboratory:

2 To view the Federal Order, go to https://www.aphis.usda.gov/plant_health/plant_pest_info/pram/downloads/pdf_files/DA-2016-34.pdf.

• Has entered into and is operating under a compliance agreement with APHIS in accordance with § 301.92-6;

• Is abiding by all terms and conditions of that compliance agreement; and

• Is approved by APHIS to test and/or analyze such samples.

We are proposing to amend paragraph (a)(2) of § 301.92-4 based on the provisions of this Federal Order.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. This proposed rule is not expected to be an Executive Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866. Further, APHIS considers this rule to be a deregulatory action under Executive Order 13771 as the action would remove regulated areas for P. ramorum from the regulations, as well as the regulatory requirements specific to such areas, thus relieving restrictions on affected entities located in those areas.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see ADDRESSES above for instructions for accessing Regulations.gov).

This proposed rule would revise the P. ramorum domestic regulations to accord with Federal Orders issued 2013-2016. The Federal Orders have allowed APHIS and State regulatory agencies to focus regulatory controls on the nurseries that present a significant risk of spreading the pathogen and away from those nurseries that pose a negligible risk of contributing to its artificial spread, thereby more efficiently apportioning resources and regulatory burden.

This proposed rule would remove the designation of P. ramorum regulated areas, as well as all restrictions and protocols specific to those areas. It would relieve the regulatory burden on approximately 1,500 nurseries where the disease is not present in the environment. As an alternative to regulated areas, this action would codify the concept of regulated establishments that would be required to enter into compliance agreement with APHIS.

The annual cost of complying with the P. ramorum management requirements in the regulations averages about $15,000 per nursery. Thus, the cost savings for the 1,500 operations relieved of these management requirements totals $22.5 million per year. In addition, by not requiring annual certification by APHIS or State officials, there are public cost savings of $252,000.

This rule would not deregulate the current P. ramorum quarantined areas, nor would it deregulate interstate shipping nurseries located within these quarantined areas. For regulated establishments and establishments located within quarantined areas, compliance costs may increase or decrease depending on amended best management practices, but any related change in operational costs is not expected to be significant. The majority of establishments affected by this rule are small entities.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the reporting, recordkeeping, and third party disclosure requirements included in this proposed rule have already been approved by the Office of Management and Budget (OMB) under OMB control numbers 0579-0088 and 0579-0310.

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.

2. Section 301.92 is amended as follows:a. By revising paragraph (b); andb. In paragraph (c), by removing the words “quarantined or regulated area” and adding the words “quarantined area or regulated establishment” in their place.

The revision reads as follows:

§ 301.92Restrictions on interstate movement.

(b) No person may move interstate from any regulated establishment any regulated, restricted, or associated articles except in accordance with this subpart.

3. Section 301.92-1 is amended as follows:a. By removing the definition of Regulated area; andb. By adding a definition of Regulated establishment in alphabetical order.

(a) Quarantined areas. (1) Except as otherwise provided in paragraph (a)(2) of this section, the Administrator will designate as a quarantined area in paragraph (a)(3) of this section each State, or each portion of a State, in which Phytophthora ramorum has been confirmed by an inspector to be established in the natural environment, in which the Administrator has reason to believe that Phytophthora ramorum is present in the natural environment, or that the Administrator considers it necessary to quarantine because of its inseparability for quarantine enforcement purposes from localities in which Phytophthora ramorum has been found in the natural environment. Less than an entire area will be designated as a quarantined area only if the Administrator determines that:

(i) The State has adopted and is enforcing restrictions on the intrastate movement of regulated, restricted, and associated articles that are substantially the same as those imposed by this subpart on the interstate movement of regulated, restricted, and associated articles; and

(ii) The designation of less than the entire State as a quarantined area will prevent the interstate spread of Phytophthora ramorum.

(2) The Administrator or an inspector may temporarily designate any nonquaratined area as a quarantined area in accordance with paragraph (a)(1) of this section. The Administrator will give a copy of this regulation along with a written notice for the temporary designation to the owner or person in possession of the nonquarantined area. Thereafter, the interstate movement of any regulated, restricted, or associated article from an area temporarily designated as a quarantined area will be subject to this subpart. As soon as practicable, this area will be added to the list in paragraph (a)(3) of this section or the designation will be terminated by the Administrator or an inspector. The owner or person in possession of an area for which designation is terminated will be given notice of the termination as soon as practicable.

(3) The following areas are designated as quarantined areas:

California

Alameda County. The entire county.

Contra Costa County. The entire county.

Humboldt County. The entire county.

Lake County. The entire county.

Marin County. The entire county.

Mendocino County. The entire county.

Monterey County. The entire county.

Napa County. The entire county.

San Francisco County. The entire county.

San Mateo County. The entire county.

Santa Clara County. The entire county.

Santa Cruz County. The entire county.

Solano County. The entire county.

Sonoma County. The entire county.

Trinity County. The entire county.

Oregon

Curry County. The following portion of Curry County that lies inside the area starting at the point where the mouth of the Rogue River meets the Pacific Ocean and continuing east along the Rogue River to the northeast corner of T35S R12W section 31; then south to the northeast corner of T38S R12W section 18; then east to the northeast corner of T38S R12W section 13; then south to northeast corner of T38S R12W section 25; then east to the northeast corner of T38S R11W section 29; then south to the northeast corner of T40S R11W section 8; then east to the northeast corner of T40S R11W section 10; then south to the State border with California; then west to the intersection of the State border and U.S. Highway 101; then northwest along U.S. Highway 101 to the intersection with West Benham Lane; then west along West Benham Lane to the Pacific Coastline; then following the Pacific Coastline northwest to the point of beginning.

(b) Regulated establishments. (1) Designation. The Administrator will designate a nursery that is not located in a quarantined area for Phytophthora ramorum as a regulated establishment for Phytophthora ramorum if the nursery ships regulated, restricted, or associated articles interstate and sources of Phytophthora ramorum are detected on nursery stock, or in soil, growing media, pots used for nursery stock, standing water, drainage water, water used for irrigation, or any other regulated, restricted, or associated articles at the nursery.

(2) Deregulation. The Administrator will withdraw regulation of a regulated establishment if, for 3 consecutive years, each time the nursery is inspected by an inspector, it is found free of sources of Phytophthora ramorum inoculum.

(Approved by the Office of Management and Budget under control number 0579-0310)6. Section 301.92-4 is amended as follows:a. By revising the section heading; andb. By revising paragraphs (a)(2) and (d).

(2) Without a certificate. (i)(A) The regulated article or associated article originated outside the quarantined area and the point of origin of the article is indicated on the waybill of the vehicle transporting the article; and

(B) The regulated or associated article is moved from outside of the quarantined area through the quarantined area without stopping except for refueling or for traffic conditions, such as traffic lights or stop signs, and the article is not unpacked or unloaded in the quarantined area.

(ii) Soil samples may be moved from a quarantined area for Phytophthora ramorum for chemical or physical (compositional) analysis provided that they are moved to a laboratory; and that laboratory:

(A) Has entered into and is operating under a compliance agreement with APHIS in accordance with § 301.92-6;

(B) Is abiding by all terms and conditions of that compliance agreement; and

(C) Is approved by APHIS to test and/or analyze such samples.

(d) Interstate movement of regulated, restricted, and associated articles from regulated establishments. Regulated, restricted, and associated articles may be moved interstate from a regulated establishment if the regulated establishment has entered into a compliance agreement with APHIS in accordance with § 301.92-6, and the articles are accompanied by a certificate issued in accordance with § 301.92-5.

7. Section 301.92-5 is amended by revising paragraphs (a)(1)(iv)(A) and (b) to read as follows:§ 301.92-5Issuance and cancellation of certificates.

(a) * * *

(1) * * *

(iv) * * *

(A)(1) Are shipped from a nursery that has been inspected in accordance with the inspection and sampling protocol described in § 301.92-11(a)(1), and the nursery is free of evidence of Phytophthora ramorum infestation; or

(2) Are shipped from a nursery that has been inspected in accordance with the inspection and sampling protocol described in § 301.92-11(a)(2), and the nursery is free of evidence of Phytophthora ramorum infestation; or

(3) Are shipped from a nursery that has been inspected in accordance with the inspection and sampling protocol described in § 301.92-11(a)(2), is not free of evidence of Phytophthora ramorum infestation, but has entered into and is operating under a compliance agreement with APHIS, and is determined by an inspector to be abiding by all terms and conditions of that agreement; and

(b) Movements from regulated establishments. An inspector may issue a certificate for the movement of regulated, restricted, and/or associated articles from a regulated establishment if the inspector determines that:

(1) The nursery has entered into a compliance agreement APHIS in accordance with § 301.92-6 and is abiding by all terms and conditions of that agreement; and

(2) The nursery has been inspected in accordance with § 301.92-11(c); and

(3) The articles to be shipped interstate are free from Phytophthora ramorum inoculum; and

(4) The movement of the articles is not subject to additional restriction under section 414 of the Plant Protection Act (7 U.S.C. 7714) or other Federal domestic plant quarantines and regulations.

§ 301.92-6 [Amended]8. Section 301.92-6 is amended as follows:a. By redesignating footnote 15 as footnote 12; andb. In the OMB citation at the end of the section, by adding the words “0579-0088 and” after the word “numbers”.§ 301.92-7 [Amended]9. In § 301.92-7, footnote 16 is redesignated as footnote 13.10. Section 301.92-11 is revised to read as follows:§ 301.92-11 Inspection and sampling protocols.

(a) Nurseries in quarantined areas shipping regulated articles of nursery stock and associated articles interstate. (1) Nurseries in which Phytophthora ramorum has not been detected since March 31, 2011. To meet the requirements of § 301.92-5(a)(1)(iv), nurseries that are located in quarantined areas, that move regulated articles of nursery stock, decorative trees without roots, wreaths, garlands, or greenery, associated articles, or non-host nursery stock interstate, and in which Phytophthora ramorum has not been detected since March 31, 2011, must meet the following requirements. Any such nurseries in quarantined areas that do not meet the following requirements are prohibited from moving regulated articles and associated articles interstate. Any such nurseries in quarantined areas that do not meet the following requirements or those in paragraph (b) of this section are prohibited from moving non-host nursery stock interstate.

(i) Annual inspection, sampling, and testing. (A) Inspection. The nursery must be inspected annually for symptoms of Phytophthora ramorum by an inspector. Inspectors will visually inspect for symptomatic plants throughout the nursery, and inspection will focus on, but not be limited to, regulated articles and associated articles.

(B) Sampling. A minimum number of plant samples must be tested per nursery location. The minimum number will be determined by APHIS on a nursery-by-nursery basis, based on the number of regulated, restricted, and associated articles contained in the nursery. Each sample may contain more than one leaf, and may come from more than one plant, but all plants in the sample must be from the same lot. Asymptomatic samples, if collected, must be taken from regulated and associated articles and nearby plants. Inspectors must conduct inspections at times when the best expression of symptoms is anticipated and must take nursery fungicide programs into consideration. Nursery owners must keep records of fungicide applications for 2 years and must make them available to inspectors upon request.

(C) Testing. Samples must be labeled and sent for testing to a laboratory approved by APHIS and must be tested using a test method approved by APHIS, in accordance with § 301.92-12.

(D) Annual certification. If all plant samples tested in accordance with this section and § 301.92-12 return negative results for Phytophthora ramorum, an inspector may certify that the nursery is free of evidence of Phytophthora ramorum infestation at the time of the inspection, and the nursery is eligible to enter into or maintain its compliance agreement in accordance with § 301.92-6.

(ii) Pre-shipment inspection, sampling, and testing. (A) Inspection. During the 30 days prior to interstate movement from a nursery in a quarantined area, regulated articles or associated articles intended for interstate movement must be inspected for symptoms of Phytophthora ramorum by an inspector. Inspection will focus on, but not be limited to, regulated articles and associated articles. No inspections of shipments will be conducted unless the nursery from which the shipment originates has a current and valid annual certification in accordance with this section.

(1) If no symptomatic plants are found upon inspection, the shipment may be considered free from evidence of Phytophthora ramorum and is eligible for interstate movement, provided that the nursery is operating under a compliance agreement with APHIS in accordance with § 301.92-6.

(2) If symptomatic plants are found upon inspection, the inspector will collect at least one sample per symptomatic plant, and one sample per regulated article or associated article that is in close proximity to, or that has had physical contact with, a symptomatic plant.

(B) Testing and withholding from interstate movement. Samples taken in accordance with this paragraph (a)(1) must be labeled and sent for testing to a laboratory approved by APHIS and must be tested using a test method approved by APHIS, in accordance with § 301.92-12. The interstate movement of plants in the shipment is prohibited until the plants in the shipment are determined to be free of evidence of Phytophthora ramorum infection in accordance with § 301.92-12.

(2) Nurseries in which Phytophthora ramorum has been detected since March 31, 2011. To meet the requirements of § 301.92-5(a)(1)(iv), nurseries that are located in quarantined areas, that move regulated articles of nursery stock, decorative trees without roots, wreaths, garlands, or greenery, associated articles, or non-host nursery stock interstate, and in which Phytophthora ramorum has been detected since March 31, 2011, must meet the following requirements. Any such nurseries in quarantined areas that do not meet the following requirements are prohibited from moving regulated articles and associated articles interstate. Any such nurseries in quarantined areas that do not meet the following requirements or those in paragraph (b) of this section are prohibited from moving non-host nursery stock interstate.

(i) Inspections. The nursery must be inspected at least twice annually for symptoms of Phytophthora ramorum infestation by an inspector. The inspection will focus on regulated plants and other potential sources of Phytophthora ramorum inoculum.

(ii) Sampling. Samples must be taken from host plants, soil, standing water, drainage water, water for irrigation, and any other articles determined by the inspector to be possible sources of Phytophthora ramorum inoculum. The number of samples taken may vary depending on the possible sources of inoculum identified at the nursery, as well as the number of host articles in the nursery.

(iii) Testing. Samples must be labeled and sent for testing to a laboratory approved by APHIS and must be tested using a test method approved by APHIS in accordance with § 301.92-12.

(iv) Negative results; certification. If all samples tested in accordance with this section and § 301.92-12 return negative results for Phytophthora ramorum, an inspector may certify that the nursery is free of Phytophthora ramorum at the time of the inspection. If the nursery is inspected and determined by an inspector to be free of Phytophthora ramorum inoculum each time it is inspected for 3 consecutive years, the nursery will thereafter be inspected in accordance with paragraph (a)(1) of this section.

(v) Positive results. If any samples tested in accordance with this section and § 301.92-12 return positive results for Phytophthora ramorum, the nursery may ship lots of regulated, restricted, and associated articles interstate pursuant to § 301.92-5(b) only if the lot is determined to be free from Phytophthora ramorum inoculum. The method for this determination will be specified in the nursery's compliance agreement with APHIS.

(b) Nurseries in quarantined areas shipping non-host nursery stock interstate. Nurseries located in quarantined areas and that move non-host nursery stock interstate must meet the requirements of this paragraph or the requirements of paragraph (a) of this section. If such nurseries contain any regulated or restricted articles, the nursery must meet the requirements of paragraph (a) of this section. This paragraph (b) only applies if there are no regulated or associated articles or nursery stock at the nursery. Nurseries that do not meet the requirements of paragraph (a) of this section or this paragraph (b) are prohibited from moving non-host nursery stock interstate.

(1) Annual visual inspection. The nursery must be visually inspected annually for symptoms of Phytophthora ramorum. Inspections and determinations of freedom from evidence of Phytophthora ramorum infestation must occur at the time when the best expression of symptoms is anticipated.

(2) Sampling. All plants showing symptoms of infection with Phytophthora ramorum upon inspection will be sampled and tested in accordance with § 301.92-12. If symptomatic plants are found upon inspection, the following plants must be withheld from interstate shipment until testing is completed and the nursery is found free of evidence of Phytophthora ramorum in accordance with this paragraph and § 301.92-12: All symptomatic plants, any plants located in the same lot as the suspect plant, and any plants located within 2 meters of this lot of plants.

(3) Certification. If all plant samples tested in accordance with this section and § 301.92-12 return negative results for Phytophthora ramorum, or if an inspector at the nursery determines that plants in a nursery exhibit no signs of infection with Phytophthora ramorum, the inspector may certify that the nursery free of evidence of Phytophthora ramorum infestation at the time of inspection. Certification is valid for 1 year and must be renewed each year to continue shipping plants interstate.

(c) Regulated establishments shipping regulated, restricted, or associated articles of interstate. (1) Inspections. To meet the conditions of § 301.92-5(b), the regulated establishment must be inspected at least twice annually for symptoms of Phytophthora ramorum infestation by an inspector. The inspection will focus on regulated plants and other potential sources of Phytophthora ramorum inoculum.

(2) Sampling. Samples must be taken from host plants, soil, standing water, drainage water, water for irrigation, growing media, and any other articles determined by the inspector to be possible sources of Phytophthora ramorum inoculum. The number of samples taken may vary depending on the possible sources of inoculum identified at the nursery, as well as the number of host articles in the nursery.

(3) Testing. Samples must be labeled and sent for testing to a laboratory approved by APHIS and must be tested using a test method approved by APHIS in accordance with § 301.92-12.

(4) Negative results; certification. If all samples tested in accordance with this section and § 301.92-12 return negative results for Phytophthora ramorum, an inspector may certify that the nursery is free of Phytophthora ramorum at the time of the inspection. For purposes of § 301.92-5(b), regulated, restricted, and associated articles at a certified nursery are considered free from Phytophthora ramorum until the time of the next inspection.

(5) Positive results. If any samples tested in accordance with this section and § 301.92-12 return positive results for Phytophthora ramorum, the nursery may ship lots of regulated, restricted, and associated articles interstate pursuant to § 301.92-5(b) only if the lot is determined to be free from Phytophthora ramorum inoculum. The method for this determination will be specified in the nursery's compliance agreement with APHIS.

□ Hand Delivery of Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday, except Federal holidays.

□ Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://regulations.gov, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.

Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday, except Federal holidays.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

Background

On August 4, 2016, Ultramagic S.A. (Ultramagic) applied for a change to Type Certificate (TC) No. B02CE 1 to include new basket Model no. CV-08 for balloon Models M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105. The CV-08 basket consists of a traditionally constructed basket, but incorporates seats with restraints and trays for all passengers, as well as a lower basket sidewall to offer a panoramic view for passengers. The CV-08 basket will be matched with one of the balloon envelopes associated with the balloon models listed in these special conditions. The volume of hot air, gores, maximum diameter, and total height defines the balloon envelope.

1See http://rgl.faa.gov/.

Most balloon baskets accommodate standing passengers. The CV-08 differs by incorporating passenger seats, restraints, and a lower basket sidewall. Due to the lower sidewall and seat configuration, passengers would need to remain seated and restrained with safety belts during flight. This configuration should consider the static strength of the installations, the possible loads in an accident, and the effect on passenger safety. Accident impact should consider safety comparison between a restrained, sitting occupant; and a normal, standing occupant. Safety requirements for balloon-seated occupants are not included in the existing airworthiness regulations. These proposed special conditions evaluate the seat installations and restraints using methods consistent with special conditions issued by the European Aviation Safety Agency (EASA). The EASA special conditions are based upon a German standard for seats in hot air airships.

Type Certification Basis

Under the provisions of § 21.101, Ultramagic must show that the M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloon models—coupled with the CV-08 basket—continues to meet the applicable provisions of the regulations incorporated by reference in TC No. B02CE or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in TC No. B02CE are as follows:

14 CFR 21.29 and part 31, effective on January, 1990, as amended by 31-1 through 31-5 inclusive.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 31) do not contain adequate or appropriate safety standards for the balloon models listed in these proposed special conditions because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model(s) for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the FAA would apply these special conditions to the other model under § 21.101.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.

EASA previously published a proposed special condition 2 (now expired) for seats and seat belts for hot air balloon baskets. EASA based the requirements of its proposed special condition on the German airworthiness requirements for Hot Air Airships LFHLLS,3 incorporating hot air balloon basket requirements for seats, seat belts, and the loads in an emergency landing condition, similar to hot air airship requirements. Ultramagic's change application applied the language in the EASA proposed special condition for CS 31HA.14(c), “Occupant mass,” CS 31HA.43(d), “Fitting factor,” CS 31HA.561(a) and (b)(1), “Emergency landing conditions—General,” and CS 31HA.785(a), (c), and (d), “Seats and seat belts” to the CV-08 basket. The FAA finds that these standards are appropriate for a seated, restrained occupant.

As discussed above, these special conditions are applicable to the Model M-56, M-56C, M-65, M-65C, M-77, M-77C, M-90, M-105, M-120, M-130, M-145, M-160, N-180, N-210, N-250, N-300, N-355, N-425, S-70, S-90, S-105, S-130, S-160, T-150, T-180, T-210, V-56, V-65, V-77, V-90, and V-105 balloons. Should Ultramagic apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the FAA would apply these special conditions to that model as well.

Conclusion

This action affects only certain novel or unusual design features on the balloon models specified in these special conditions. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane. These proposed special conditions are identical in intent to the EASA special conditions, although the formatting has been altered to meet these special condition requirements.

For calculation purposes, it should be assumed the mass of an occupant is at least 86 kilograms (190 pounds).

b. Seats, Safety Belts, and Harnesses Factor of Safety

For each seat, safety belt, and harness, its attachment to the structure must be shown, by analysis, tests, or both, to be able to withstand the inertia forces prescribed in paragraph (c) of these special conditions multiplied by a fitting factor of 1.33.

c. Emergency Landing Conditions—General

The balloon—although it may be damaged under emergency landing conditions—must be designed to give each occupant every reasonable chance of avoiding serious injury in a crash landing—when seat belts provided for in the design are properly used—and the occupant is subject to the following ultimate inertia forces acting relative to the surrounding structure as well as independently of each other.

(1) Forward 6g(2) Sideways 6g(3) Downward 6gd. Seats and Seatbelts

(1) Each seat and its supporting structure must be designed for an occupant mass in accordance paragraph (a) of these special conditions and for the maximum load factors corresponding to the specified flight and ground load conditions, including the emergency landing conditions prescribed in paragraph (c) of these special conditions.

(2) Each seat or berth shall be fitted with an individual approved seat belt or harness.

(3) Seat belts installed on the balloon must not fail under flight or ground load conditions or emergency landing conditions in accordance with paragraph (c) of these special conditions, taking into account the geometrical arrangement of the belt attachment and the seat.

We propose to supersede Airworthiness Directive (AD) 2017-07-04, which applies to General Electric Company (GE) GE90-110B1 and GE90-115B turbofan engines with certain high-pressure compressor (HPC) rotor stage 2-5 spools installed. AD 2017-07-04 resulted from reports of cracks in HPC rotor stage 2-5 spool aft spacer arms. Since we issued AD 2017-07-04, GE released a new service bulletin (SB) that increases the number of affected HPC rotor stage 2-5 spools. Additionally, we learned that we inadvertently omitted certain HPC rotor stage 2-5 spools from the applicability of AD 2017-07-04. This proposed AD would require removing certain HPC rotor stage 2-5 spools from service before reaching the new reduced life limit and replacing them with parts eligible for installation. We are proposing this AD to correct the unsafe condition on these products.

DATES:

We must receive comments on this proposed AD by August 9, 2018.

ADDRESSES:

You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

For service information identified in this NPRM, contact General Electric Company, One Neumann Way, Room 285, Cincinnati, OH; phone: 513-552-3272; email: geae.aoc@ge.com. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759.

Examining the AD Docket

You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0406; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0406; Product Identifier 2013-NE-30-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Discussion

We issued AD 2017-07-04, Amendment 39-18842 (82 FR 16728, April 6, 2017), (“AD 2017-07-04”), for GE GE90-110B1 and GE90-115B turbofan engines with certain HPC rotor stage 2-5 spools installed. AD 2017-07-04 requires removing these spools from service at times determined by a drawdown plan. AD 2017-07-04 resulted from reports of cracks in HPC rotor stage 2-5 spool aft spacer arms. We issued AD 2017-07-04 to prevent failure of a critical life-limited rotating engine part, which could result in an uncontained engine failure and damage to the airplane.

Actions Since AD 2017-07-04 Was Issued

Since we issued AD 2017-07-04, GE released GE SB GE90-100 SB 72-0714 R01, dated February 16, 2018, for the HPC rotor stage 2-5 spools, which increases the number of affected parts.

GE SB GE90-100 SB 72-0499 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use the original seal tooth coating process. GE SB GE90-100 SB 72-0659 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use a modified seal tooth coating process. GE SB GE90-100 SB 72-0714 R01 describes procedures for identification and removal from service of HPC rotor stage 2-5 spools that use the modified seal tooth coating process, without coating between the seal teeth.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

Proposed AD Requirements

This proposed AD would retain all requirements of AD 2017-07-04. This proposed AD would require removing certain HPC rotor stage 2-5 spools from service at times specified in the required actions section.

Costs of Compliance

We estimate that this proposed AD affects 85 engines installed on airplanes of U.S. registry.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

Regulatory Findings

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This AD was prompted by reports of cracks in HPC rotor stage 2-5 spool aft spacer arms. We are issuing this AD to prevent failure of the HPC rotor stage 2-5 spools. The unsafe condition, if not addressed, could result in uncontained spool release, damage to the engine, and damage to the airplane.

(f) Compliance

Comply with this AD within the compliance times specified, unless already done.

(1) After the effective date of this AD, do not install or reinstall onto any engine, any HPC rotor stage 2-5 spool with a serial number listed in paragraph 4, Appendix A, of GE SB No. GE90-100 SB 72-0499 R01, dated February 5, 2014, or paragraph 4, Appendix A, of GE SB GE90-100 SB72-0659 R01, dated February 18, 2016, that exceeds 5,000 CSN.

(2) After the effective date of this AD, do not install or reinstall onto any engine, any HPC rotor stage 2-5 spool listed in paragraph (c)(2) of this AD, or HPC rotor stage 2-5 spool with a serial number listed in paragraph 4, Appendix A, of GE SB GE90-100 SB 72-0714 R01, dated February 16, 2018, that exceeds 8,200 CSN.

(i) Alternative Methods of Compliance (AMOCs)

(1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. You may email your request to: ANE-AD-AMOC@faa.gov.

(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(2) For service information identified in this AD, contact General Electric Company, One Neumann Way, Room 285, Cincinnati, OH; phone: 513-552-3272; email: geae.aoc@ge.com. You may view this referenced service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759.

We propose to adopt a new airworthiness directive (AD) for certain Airbus Defense and Space S.A. Model C-212-CB, C-212-CC, C-212-CD, C-212-CE, and C-212-DF airplanes. This proposed AD was prompted by reports of failures of the rudder pedal control system support. This proposed AD would require repetitive detailed visual inspections of the rudder pedal control system support box and shaft and applicable corrective actions. We are proposing this AD to address the unsafe condition on these products.

DATES:

We must receive comments on this proposed AD by August 9, 2018.

ADDRESSES:

You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0552; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0552; Product Identifier 2018-NM-049-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this NPRM.

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0051, dated March 2, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Defense and Space S.A. Model C-212-CB, C-212-CC, C-212-CD, C-212-CE, and C-212-DF airplanes. The MCAI states:

Failures were reported of the rudder pedal control system support on CASA C-212 aeroplanes. Subsequent investigation revealed that the welding area of the affected support structure had broken.

This condition, if not corrected, could lead to failure of the rudder [pedal] control system, possibly resulting in reduced control of the aeroplane.

To address this potential unsafe condition, EADS-CASA issued the SB [EADS-CASA Service Bulletin SB-212-27-0057, dated May 21, 2014] to provide modification instructions and EASA issued AD 2017-0036 [which corresponds to FAA AD 2017-19-08, Amendment 39-19038 (82 FR 43835, September 20 2017) (“AD 2017-19-08”)] to require that modification [of the rudder pedal adjustment system]. During accomplishment of that modification, several operators reported difficulties or impossibility to follow the accomplishment instruction. Consequently, EASA and Airbus D&S [Defense and Space S.A.] reviewed the difficulty reports and decided that the modification instructions have to be improved.

Pending the improvement of the instructions of the SB [EADS-CASA Service Bulletin SB-212-27-0057, dated May 21, 2014] and in order to reduce the risk of failure of the [rudder] pedal adjustment system to an acceptable level, Airbus D&S issued the inspection AOT [Airbus Alert Operators Transmission AOT-C212-27-0002, dated February 28, 2018] to provide instructions to repetitively inspect the affected parts [rudder pedal support box Part Number (P/N) 212-46195.1 and shaft P/N 212-46120-20].

For the reasons described above, this [EASA] AD cancels the requirements of EASA AD 2017-0036, which is superseded, and requires repetitive [detailed visual] inspections of the rudder pedal adjustment system [rudder pedal support box P/N 212-46195.1 and shaft P/N 212-46120-20] and, depending on findings, accomplishment of applicable corrective action(s).

This [EASA] AD is considered to be an interim action and further [EASA] AD action may follow.

Corrective actions include obtaining corrective actions approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus Defense and Space S.A.'s EASA Design Organization Approval (DOA); and accomplishing the corrective actions within the compliance time specified therein. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0552.

Relationship Between Proposed AD and AD 2017-19-08

This NPRM does not propose to supersede AD 2017-19-08. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This proposed AD would require repetitive detailed visual inspections of the rudder pedal control system support box and shaft and applicable corrective actions. Accomplishment of the proposed actions would then terminate all of the requirements of AD 2017-19-08.

Related Service Information Under 1 CFR Part 51

Airbus Defense and Space S.A. has issued Airbus Alert Operators Transmission AOT-C212-27-0002, dated February 28, 2018. The service information describes procedures for repetitive detailed visual inspections of the rudder pedal control system support box and shaft. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Costs of Compliance

We estimate that this proposed AD affects 36 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

Estimated Costs for Required ActionsLabor costParts costCost per

product

Cost on U.S.

operators

Up to 8 work-hours × $85 per hour = Up to $680$0Up to $680Up to $24,480.

We have received no definitive data that would enable us to provide cost estimates for the on-condition repair specified in this proposed AD.

Authority for This Rulemaking

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.

Regulatory Findings

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This AD was prompted by reports of failures of the rudder pedal control system support. We are issuing this AD to prevent failure of the rudder control system, which could result in reduced controllability of the airplane.

(f) Compliance

Comply with this AD within the compliance times specified, unless already done.

(g) Definitions

(1) For the purposes of this AD, an affected part is defined as a rudder pedal support box having Part Number (P/N) 212-46195.1 and shaft P/N 212-46120-20.

(2) For the purposes of this AD, a discrepancy or defect of the rudder pedal support box P/N 212-46195.1 is defined as any crack or deformation on any welded area.

(3) For the purposes of this AD, a discrepancy or defect of the shaft P/N 212-46120-20 is defined as any crack or deformation.

(h) Repetitive Detailed Visual Inspections

Within 3 months or during the next scheduled A-check maintenance, whichever occurs first after the effective date of this AD, and thereafter, at intervals not to exceed 150 flight hours, do a detailed visual inspection of each affected part in accordance with the instructions of Airbus Alert Operators Transmission AOT-C212-27-0002, dated February 28, 2018.

(i) Corrective Action for Any Discrepancy or Defect

If any discrepancy or defect is detected during any inspection required by paragraph (h) of this AD: Before further flight, obtain corrective actions approved by the Manager, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Airbus Defense and Space S.A.'s EASA Design Organization Approval (DOA); and accomplish the corrective actions within the compliance time specified therein. If approved by the DOA, the approval must include the DOA-authorized signature. Accomplishment of a repair, as required by this paragraph, does not constitute terminating action for the repetitive inspections required by paragraph (h) of this AD.

(j) Parts Installation Limitation

As of the effective date of this AD, an affected part may be installed on any airplane provided that it is a new part or that, before installation, the visual inspection required by paragraph (h) of this AD has been accomplished on that part and the part passed the inspection (no discrepancy or defect detected), as required by paragraph (h) of this AD.

(k) Terminating Action for AD 2017-19-08

Accomplishing the actions required by this AD terminates all of the requirements of AD 2017-19-08.

(l) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, International Section, Transport Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Section, send it to the attention of the person identified in paragraph (m)(2) of this AD. Information may be emailed to: 9-ANM-116-AMOC-REQUESTS@faa.gov. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or EASA; or Airbus Defense and Space S.A.'s EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

(m) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0051, dated March 2, 2018, for related information. This MCAI may be found in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0552.

We propose to supersede Airworthiness Directive (AD) 2018-02-14, which applies to certain Honeywell International Inc. (Honeywell) TPE331 turboprop and TSE331 turboshaft engines. AD 2018-02-14 requires inspection of the affected combustion chamber case assembly, replacement of those assemblies found cracked, and removal of affected assemblies on certain TPE331 and TSE331 engines. Since we issued AD 2018-02-14, we received comments to revise the applicability of that AD to include the TPE331-12B engine model, correct certain TPE engine model typographical errors, and to allow certain weld repair procedures. This proposed AD would expand the applicability of AD 2018-02-14 to include the TPE331-12B engine model, correct certain engine model typographical errors, and allow certain weld repair procedures after approval. We are proposing this AD to address the unsafe condition on these products.

DATES:

We must receive comments on this proposed AD by August 9, 2018.

ADDRESSES:

You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

For service information identified in this NPRM, contact Honeywell International Inc., 111 S 34th Street, Phoenix, AZ 85034-2802; phone: 800-601-3099; internet: https://myaerospace.honeywell.com/wps/portal. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759.

Examining the AD Docket

You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0479; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (phone: 800-647-5527) is listed above. Comments will be available in the AD docket shortly after receipt.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0479; Product Identifier 2016-NE-23-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

Since we issued AD 2018-02-14, we determined the need to revise sections of that AD. We received comments indicating that the TPE331-12B engine model was inadvertently omitted from that AD and that the TPE331-43-A, -43-BL, -47-A, -55-B, and -61-A engine models included typographical errors. We also received comments to revise the Compliance section, which disallows weld repairs on any combustion chamber case assemblies that are affected by that AD. We determined that allowing weld repair procedures of certain combustion chamber case assemblies with lower stresses may be accomplished if these procedures are approved by the Manager, Los Angeles ACO Branch.

Related Service Information Under 1 CFR Part 51

We reviewed Honeywell Service Bulletin (SB) TPE331-72-2178, Revision 0, dated May 3, 2011 and Honeywell SB TPE331-72-2179, Revision 0, dated May 3, 2011. Honeywell SB TPE331-72-2178, Revision 0, describes procedures for inspection and removal of the affected combustion chamber case assemblies installed on all affected engines except for the TPE331-12B engine model. Honeywell SB TPE331-72-2179, Revision 0, describes procedures for inspection and removal of the affected combustion chamber case assemblies installed on the TPE331-12B engine model. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

Proposed AD Requirements

This proposed AD would retain all of the requirements of AD 2018-02-14. This proposed AD would revise the Applicability to include the TPE331-12B engine model and to correct references to the TPE331-43-A, -43-BL, -47-A, -55-B, and -61-A engine models. This proposed AD would also allow weld repair procedures to the applicable combustion chamber case assemblies provided those procedures are approved by the Manager, Los Angeles ACO Branch.

Costs of Compliance

We estimate that this AD affects 5,644 engines installed on airplanes of U.S. registry.

We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We estimate that 158 engines will need this replacement during the first year of inspection.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

Regulatory Findings

We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the proposed regulation:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This AD was prompted by reports that combustion chamber case assemblies have cracked and ruptured. We are issuing this AD to prevent failure of the combustion chamber case assembly. The unsafe condition, if not addressed, could result in failure of the combustion chamber case assembly, in-flight shutdown, and reduced control of the airplane.

(f) Compliance

Comply with this AD within the compliance times specified, unless already done.

(g) Required Actions

(1) For all affected engines:

(i) Inspect all accessible areas of the combustion chamber case assembly, focusing on the weld joints, before accumulating 450 hours time in service (TIS) since last fuel nozzle inspection or within 50 hours TIS after the effective date of this AD, whichever occurs later.

(ii) Perform the inspection in accordance with the Accomplishment Instructions, paragraphs 3.B.(1) through 3.B.(2), in Honeywell Service Bulletin (SB) TPE331-72-2178, Revision 0, dated May 3, 2011, or SB TPE331-72-2179, Revision 0, dated May 3, 2011, as applicable to the affected engine model.

(iii) Thereafter, repeat this inspection during scheduled fuel nozzle inspections at intervals not to exceed 450 hours TIS since the last fuel nozzle inspection.

(2) For TPE331-3U, -3UW, -5, -5A, -5AB, -5B, -6, and -6A engine models with combustion chamber case assemblies, P/Ns 869728-1, 869728-3, or 893973-5, installed, and without the one-piece bleed pad with P3 boss; and for TPE331-1, -2, and -2UA engine models modified by National Flight Services, Inc., supplemental type certificate (STC) SE383CH, remove the combustion chamber case assembly from service at the next removal of the combustion chamber case assembly from the engine, not to exceed 3,700 hours TIS since last hot section inspection.

(3) After the effective date of this AD, do not weld repair the applicable combustion chamber case assemblies unless the weld repair procedures are approved by the Manager, Los Angeles ACO Branch, and that approval specifically refers to this AD.

(h) Definition

(1) TPE331 engines modified by STC SE383CH may be defined as the “Super 1” and “Super 2” for the compressor modification of the TPE331-1 and the TPE331-2, -2U, and -2UA engine models, respectively.

(2) Figures 1 and 2 to paragraph (h) of this AD illustrate the appearance of combustion chamber case assembly, P/N 893973-5, without and with, respectively, the one-piece bleed pad with the P3 boss.

After the effective date of this AD, do not install a combustion chamber case assembly, P/N 869728-1, 869728-3, or 893973-5, in TPE331-3U, -3UW, -5, -5A, -5AB, -5B, -6, and -6A engine models or in TPE331-1, -2, and -2UA engine models modified by National Flight Services, Inc., STC SE383CH, unless the combustion chamber case assembly has a one-piece bleed pad with P3 boss.

(j) Alternative Methods of Compliance (AMOCs)

(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to: 9-ANM-LAACO-AMOC-REQUESTS@faa.gov.

(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

(2) For service information identified in this AD, contact AD, contact Honeywell International Inc., 111 S 34th Street, Phoenix, AZ 85034-2802; phone: 800-601-3099; internet: https://myaerospace.honeywell.com/wps/portal. You may view this service information at the FAA, Engine and Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7759.

The Environmental Protection Agency (EPA) is proposing to approve and conditionally approve revisions to the San Diego County Air Pollution Control District's (SDAPCD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern the District's New Source Review (NSR) permitting program for new and modified sources of air pollution under section 110(a)(2)(C) and part D of title I of the Clean Air Act (CAA). This action updates the SDAPCD's applicable SIP with current SDAPCD permitting rules. We are taking comments on this proposal and plan to follow with a final action.

DATES:

Any comments must arrive by July 25, 2018.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R09-OAR-2018-0233 at http://www.regulations.gov, or via email to R9AirPermits@epa.gov. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Ya-Ting Tsai, EPA Region IX, (415) 972-3328, Tsai.Ya-Ting@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, “we,” “us” and “our” refer to the EPA.

Table of Contents I. The State's SubmittalA. What rules did the State submit?B. Are there other versions of these rules?C. What is the purpose of the submitted rule revisions?II. The EPA's Evaluation and ActionA. How is the EPA evaluating the rules?B. Do the rules meet the evaluation criteria?C. Proposed Action and Public CommentIII. Incorporation by ReferenceIV. Statutory and Executive Order ReviewsI. The State's SubmittalA. What rules did the State submit?

Table 1 lists the rules addressed by this proposal with the dates when they were adopted by the SDAPCD and submitted by the California Air Resources Board (CARB), which is the governor's designee for California SIP submittals. Collectively, these submittals generally constitute the SDAPCD's current program for preconstruction review and permitting of new or modified stationary sources under its jurisdiction. The rule revisions that are the subject of this action represent a comprehensive revision to the SDAPCD's preconstruction review and permitting program and are intended to satisfy the requirements under part D of title I of the Act (nonattainment NSR or NNSR) as well as the general preconstruction review requirements under section 110(a)(2)(C) of the Act (minor NSR). The SDAPCD does not implement a SIP-approved prevention of significant deterioration (PSD) permitting program and has not submitted the rules in this action for purposes of the PSD program; therefore, we are not evaluating whether this SIP submittal satisfies PSD program requirements at 40 CFR 51.166.

On October 14, 2016, the EPA determined that the submittal of Rules 20.1, 20.2, 20.3, 20.4 and 20.6 met the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review. On September 27, 2016, we determined that the submitted versions of Rules 11 and 24 met these completeness criteria. On May 21, 1987, the submittal of Rule 20 was deemed complete by operation of law.

In addition to these SIP submittals, on April 27, 2018 the District and CARB transmitted a commitment letter to the EPA to adopt and submit specific enforceable measures by July 31, 2019 to address deficiencies in the submitted rules identified by the EPA.1

The EPA last approved significant revisions or updates to the SDAPCD's SIP-approved NSR program in the 1980s. The existing SIP-approved NSR program for new or modified stationary sources under the SDAPCD's jurisdiction generally consists of the versions of the rules identified below in Table 2.

Collectively, these regulations establish the NSR requirements that are currently in place for both major and minor stationary sources under the SDAPCD's jurisdiction in California. If the EPA finalizes the action proposed herein, these rules will be replaced in the SIP by the submitted set of rules listed in Table 1.

2 The EPA approved Rule 11 in its entirety for incorporation into the California SIP in September 22, 1972 (37 FR 19812) and approved revisions in 1982.

C. What is the purpose of the submitted rule revisions?

As noted above and described in further detail below, the submitted rules are intended to satisfy the minor NSR and NNSR requirements of section 110(a)(2)(C) and part D of title I of the Act, and related EPA regulations. Minor NSR requirements are generally applicable for SIPs in all areas, while NNSR requirements apply only for areas designated as nonattainment for one or more National Ambient Air Quality Standards (NAAQS). San Diego County is currently classified as a “moderate” nonattainment area for the 2008 8-hour ozone NAAQS and is designated attainment or unclassifiable for all other NAAQS. See 40 CFR 81.305. Therefore, in addition to being subject to the requirements for minor NSR at section 110(a)(2)(C) of the Act, California is required to adopt and implement a SIP-approved NNSR permitting program that applies to new or modified major stationary sources of ozone and ozone precursors within the San Diego County nonattainment area, under part D of title I of the Act.

II. The EPA's Evaluation and ActionA. How is the EPA evaluating the rules?

The EPA has evaluated the submitted rules for compliance with applicable requirements of section 110(a)(2)(C) and part D of title I of the CAA and associated regulations at 40 CFR 51.160-165, consistent with the District's current classification as a “moderate” nonattainment area for the 2008 8-hour ozone NAAQS. We have also reviewed the rules for consistency with other CAA general requirements for SIP submittals, including requirements at section 110(a)(2) regarding rule enforceability, and requirements at sections 110(l) and 193 for SIP revisions.

Section 110(a)(2)(C) of the Act requires each SIP to include a program to regulate the modification and construction of any stationary source within the areas covered by the SIP as necessary to assure attainment and maintenance of the NAAQS. The EPA's regulations at 40 CFR 51.160-51.164 provide general programmatic requirements to implement this statutory mandate. These requirements, commonly referred to as the “minor NSR” or “general NSR” program, apply generally to both major and non-major stationary sources and modifications and in both attainment and nonattainment areas, in contrast to the specific statutory and regulatory requirements for PSD and NNSR permitting programs under parts C and D of title I of the Act that apply to major sources in attainment and nonattainment areas, respectively.

Part D of title I of the Act, and the implementing regulations at 40 CFR 51.165, contain the NNSR program requirements for major stationary sources and major modifications (as those terms are defined at 40 CFR 51.165) at facilities that are located in a nonattainment area and are major sources for the pollutants for which the area has been designated nonattainment.

The SDAPCD has elected not to submit rules to satisfy requirements of the PSD program under part C of title I of the Act for major stationary sources in attainment areas at this time. Accordingly, the EPA is not evaluating whether this SIP submittal satisfies PSD program requirements at 40 CFR 51.166, and some portions of Rules 20.2-20.4 addressing major sources in attainment areas are excluded from the submittal. See Table 1. The EPA remains the PSD permitting authority in San Diego County.

Section 110(a)(2)(A) of the Act requires that regulations submitted to the EPA for SIP approval must be clear and legally enforceable. Section 110(l) of the Act prohibits the EPA from approving any SIP revisions that would interfere with any applicable requirement concerning attainment and reasonable further progress (RFP) or any other applicable requirement of the CAA. Section 193 of the Act prohibits the modification of a SIP-approved control requirement in effect before November 15, 1990 in a nonattainment area, unless the modification ensures equivalent or greater emission reductions of the relevant pollutant(s). With respect to procedures, CAA sections 110(a) and 110(l) require that a state conduct reasonable notice and hearing before adopting a SIP revision.

B. Do the rules meet the evaluation criteria?

With the exceptions noted below, the EPA finds that the submitted rules generally satisfy the applicable CAA and regulatory requirements. Accordingly, we are proposing to fully approve Rules 11, 20, and 24 under CAA section 110(k)(3), and to conditionally approve Rules 20.1, 20.2, 20.3, 20.4, and 20.6 under CAA section 110(k)(4). Below, we discuss generally our evaluation of the submitted rules. The technical support document (TSD) included in the docket for this proposed rulemaking contains a more detailed analysis.

We find that the submitted rules satisfy the minor NSR requirements. The rules clearly identify the kinds of projects subject to review under the District's program, include legally enforceable procedures to ensure that construction will not violate the state's control strategy or interfere with attainment or maintenance of the NAAQS, provide for public availability of relevant information, and meet other requirements of the minor NSR regulations at 40 CFR 51.160-164. In general, Rules 11, 20, 20.1, 20.6 and 24 incorporate general regulatory requirements of the minor NSR program, while Rules 20.2, 20.3, and 20.4 apply applicable elements of the program to minor stationary sources, major stationary sources, and portable emission units, respectively.

We find that the submitted rules satisfy nearly all applicable statutory and regulatory NNSR requirements, including definitions, applicability procedures, and requirements for sources in nonattainment areas to obtain emission reduction offsets and comply with the lowest achievable emissions rate. These requirements are met substantially through Rule 20.1, and other elements are addressed in Rules 20.2-20.4. The EPA has identified two deficiencies in the rules. First, the submitted rules do not contain recordkeeping and reporting requirements for sources using an actual-to-potential-actual test to determine applicability of major source requirements. The submitted Rule 20.1 provides an option for sources to use the federal actual-to-potential-actual test under 40 CFR 51.165(a)(2)(ii)(B) through (F); however, the rule does not include associated provisions at 40 CFR 51.165(a)(6) and (7) that require these sources to comply with recordkeeping and reporting requirements. Second, the rules do not incorporate the requirement at section 173(a)(4) of the Act, which states that NNSR permit programs shall provide that permits to construct and operate may not be issued if the EPA Administrator has determined that the applicable implementation plan for the nonattainment area is not being adequately implemented. As described below, these deficiencies are the basis for the EPA's proposed conditional approval of the District's June 17, 2016 submittal.

The submitted rules comply with the substantive and procedural requirements of CAA section 110(l). With respect to the procedural requirements, based on our review of the public process documentation included with the submitted rules, we find that the SDAPCD has provided sufficient evidence of public notice and opportunity for comment and public hearings prior to submittal of this SIP revision and has satisfied these procedural requirements under CAA section 110(l).

With respect to the substantive requirements of CAA section 110(l), we have determined that our approval of the submitted rules would strengthen the applicable SIP. The current SIP-approved San Diego NNSR program is significantly out of date when compared with current federal NNSR regulatory requirements, and the updated versions of the submitted rules bring the program up to date with current requirements. As a whole, the submitted rules are more stringent and will be more protective of air quality in San Diego County, and we have determined that our approval of this SIP submittal would not interfere with any applicable requirement concerning attainment and RFP or any other applicable requirement of the Act.

Similarly, we find that the submitted rules are approvable under section 193 of the Act. Most of the submitted rules were last approved prior to November 15, 1990, and are subject to the general requirement to ensure equivalent or greater emission reductions. We have determined that the submitted rules will ensure greater reductions overall relative to the SIP-approved version of the rules.

The submitted rules are otherwise consistent with criteria for the EPA's approval of regulations submitted for inclusion in the SIP, including the requirement at CAA section 110(c)(2)(A) that submitted regulations be clear and legally enforceable.

For the reasons stated above and explained further in our TSD, we find that the submitted NSR rules generally satisfy the applicable CAA and regulatory requirements for minor NSR and NNSR permit programs under CAA section 110(a)(2)(C) and part D of title I of the Act and other applicable requirements, subject to the two exceptions noted above where the EPA has identified a deficiency. For those exceptions, the District and CARB have committed to adopt and submit revisions to address the identified deficiencies within a year of the date of approval, consistent with the requirements at CAA section 110(k)(4) for conditional approval.

C. Proposed Action and Public Comment

Based on our evaluation of the submitted rules, the EPA is proposing to fully approve the SDAPCD's August 22, 2016 and November 21, 1986 submittals (consisting of Rules 11, 20, and 24), and to conditionally approve the District's June 17, 2016 submittal (consisting of Rules 20.1, 20.2, 20.3, 20.4, and 20.6). Under CAA section 110(k)(3), the EPA may approve a plan revision in whole or in part if it meets all applicable requirements. Under CAA section 110(k)(4), the EPA may conditionally approve a plan revision based on a commitment by the state to adopt specific enforceable measures by a date certain but not later than one year after the date of the plan approval.

As described above, the EPA has determined that the submitted rules generally comply with most applicable requirements, but do not satisfy the requirements at 40 CFR 51.165(a)(6) and (7) and section 173(a)(4) of the Act. On April 16, 2018, the District transmitted to CARB and the EPA a commitment to revise the submitted rules by amending Rule 20.1 to incorporate the requirements at 40 CFR 51.165(a)(6) and (7) and by amending Rule 20.3 to incorporate the requirement at CAA section 173(a)(4), and to transmit the revised rules to CARB no later than June 30, 2019. The amendments to Rules 20.1 and 20.3 as described above will cure the deficiencies in Rules 20.2, 20.4, and 20.6. On April 27, 2018, CARB committed to submit these rules to the EPA no later than July 31, 2019. These letters commit the District to adopt specific enforceable measures to correct the rule deficiencies and commit the state to submit them to the EPA by a date certain, and the EPA has determined that if the District adopts and submits these revisions as committed, the identified deficiencies will be cured. Accordingly, we find that these commitment letters are consistent with CAA requirements regarding conditional approval at CAA section 110(k)(4).

The intended effect of our proposed conditional approval action is to update the applicable SIP with current SDAPCD rules and provide the SDAPCD the opportunity to correct the identified deficiencies. If we finalize this action as proposed, our action would be codified through revisions to 40 CFR 52.220 (Identification of plan—in part) and 40 CFR 52.248 (Identification of plan—conditional approval).

If the State meets its commitment to submit the required measures and the EPA approves the submission, then the deficiencies listed above will be cured. However, if the District fails to submit these revisions within the required timeframe, the conditional approval will become a disapproval, and the EPA will issue a finding of disapproval. The EPA is not required to propose the finding of disapproval. Further, a finding of disapproval would start an 18-month clock to apply sanctions under CAA section 179(b) and a two-year clock for a federal implementation plan under CAA section 110(c)(1).

We will accept comments from the public on this proposal until July 25, 2018.

III. Incorporation by Reference

In this document, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the SDAPCD rules described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

Under the CAA, the EPA Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Environmental Protection Agency (EPA) is proposing to approve a request from the Missouri Department of Natural Resources (MDNR) to redesignate the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL nonattainment area (“St. Louis area” or “area”) to attainment for the 2008 ozone National Ambient Air Quality Standard (NAAQS). MDNR submitted this request on September 12, 2016, with a supplemental submission on February 16, 2018, to include a revised motor vehicle emissions budget. EPA is proposing this action because the request meets the statutory requirements for redesignation under the Clean Air Act (CAA). As part of this action, EPA is also proposing to approve, as a revision to the Missouri State Implementation Plan (SIP), the state's plan for maintaining the 2008 8-hour ozone NAAQS through 2030. Finally, EPA finds adequate and is proposing to approve, as a SIP revision, the State's 2030 volatile organic compound (VOC) and oxides of nitrogen (NOX) Motor Vehicle Emission Budgets (MVEBs) for the Missouri portion of the St. Louis area. EPA addressed the Illinois portion of the St. Louis area in a separate rulemaking action on March 1, 2018. 83 FR 8756.

DATES:

Comments must be received on or before July 25, 2018.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R07-OAR-2017-0349, to https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

Table of ContentsI. What is being addressed in this document?II. Background InformationIII. What are the criteria for redesignation?IV. What is EPA's analysis of Missouri's redesignation request?A. Criteria (1)—The St. Louis Area Has Attained the 2008 8-Hour Ozone NAAQSB. Criteria (2)—Missouri Has a Fully Approved SIP Under Section 110(k) for the St. Louis Area; and Criteria (5) Missouri Has Met All Applicable Requirements for the St. Louis Area of Section 110 and Part D of the CAAC. Criteria (3)—The Air Quality Improvement in the St. Louis Area Is Due to Permanent and Enforceable Emission ReductionsD. Criteria (4)—The Area Has a Fully Approvable Ozone Maintenance Plan Pursant to Section 175 of the CAAV. Has the State adopted approvable motor vehicle emission budgets?A. Motor Vehicle Emission BudgetsB. What is the status of the EPA's adequacy determination for the proposed VOC and NOX MVEBs for the St. Louis area?C. What is a safety margin?VI. Proposed ActionVII. Statutory and Executive Order ReviewsI. What is being addressed in this document?

EPA is proposing to approve MDNR's request to change the designation of the Missouri portion of the St. Louis area from nonattainment to attainment for the 2008 ozone NAAQS, based on quality-assured and certified data monitoring data for 2013-2015, and that the Missouri portion of the St. Louis area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.

EPA is also proposing to approve the state's maintenance plan as a revision to the Missouri SIP; the maintenance plan is designed to keep the Missouri portion of the St. Louis area in attainment of the 2008 ozone NAAQS through 2030.

Finally, EPA finds adequate and is proposing to approve into the SIP the newly-established 2030 MVEBs for the area. The adequacy comment period for the MVEBs began on April 10, 2018, with EPA's posting of the availability of Missouri's submittal on EPA's Adequacy website (at https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity). The adequacy comment period for these MVEBs ended on May 10, 2018. EPA did not receive any adverse comments on this submittal during the adequacy comment period. In a letter dated May 15, 2018, EPA informed Missouri that the 2030 MVEBs are adequate for use in transportation conformity analyses. Please see section V.B. of this rulemaking, “What is the status of EPA's adequacy determination for the proposed VOC and NOX MVEBs for the St. Louis area?” for further explanation of this process.

II. Background Information

EPA has determined that ground-level ozone is detrimental to human health. On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is attained when the three-year average of the annual fourth highest daily maximum 8-hour average concentration is equal to or less than 0.075 ppm at all of the ozone monitoring sites in the area. See 40 CFR 50.15 and appendix P to 40 CFR part 50.

Upon promulgation of a new or revised NAAQS, section 107(d)(1)(B) of the CAA requires EPA to designate as nonattainment any areas that are violating the NAAQS based on the most recent three years of quality assured ozone monitoring data. The St. Louis area was designated as a marginal nonattainment area for the 2008 ozone NAAQS on May 21, 2012 (77 FR 30088); the designation became effective on July 20, 2012.

In a final implementation rule for the 2008 ozone NAAQS (SIP Requirements Rule),1 EPA established ozone standard attainment dates based on table 1 of CAA section 181(a). For the areas classified as marginal nonattainment, this established an attainment date three years after the July 20, 2012 effective date.

1 This rule, titled “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements,” published on March 6, 2015. 80 FR 12264. The rule addresses nonattainment area SIP requirements for the 2008 ozone NAAQS, including requirements pertaining to attainment demonstrations, reasonable further progress (RFP), reasonably available control technology (RACT), reasonably available control measures (RACM), new source review (NSR), emission inventories, and the timing requirements for SIP submissions and compliance with emission control measures in the SIP. This rule also addresses the revocation of the 1997 ozone NAAQS and the antibacksliding requirements that apply when the 1997 ozone NAAQS is revoked.

CAA section 181(b)(2) requires EPA to determine, based on an area's ozone design value as of the area's attainment deadline, whether the area has attained the ozone standard by that date. The statute provides a mechanism by which states that meet certain criteria may request, and be granted by the Administrator, a one year extension of an area's attainment deadline. On May 4, 2016, based on EPA's evaluation and determination that the areas met the criteria of CAA section 181(a)(5), EPA granted the St. Louis area a one year extension of the marginal area attainment date; the revised attainment date became July 20, 2016. 81 FR 26697.

On June 27, 2016, in accordance with CAA section 181(b)(2)(A) and the provisions of the SIP Requirements Rule, EPA determined that the St. Louis area attained the 2008 8-hour ozone standard by its July 20, 2016, attainment date. 81 FR 41444. EPA's determination was based upon three years of complete, quality assured and certified data for the 2013-2015 time period.

On September 12, 2016, with a supplemental revision on February 16, 2018, Missouri submitted to EPA a request to redesignate the Missouri portion of the St. Louis area, to attainment for the 2008 ozone NAAQS, and to approve the maintenance plan for that area, including the 2030 MVEBs, as a revision to the SIP.

III. What are the criteria for redesignation?

Section 107(d)(3)(E) of the CAA allows redesignation of a nonattainment area to attainment of the NAAQS provided that: (1) The Administrator determines that the area has attained the NAAQS; (2) the Administrator has fully approved the applicable implementation plan for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP, applicable Federal air pollutant control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A of the CAA; and (5) the state containing the area has met all requirements applicable to the area for the purposes of redesignation under section 110 and part D of the CAA.

On April 16, 1992, EPA provided guidance on redesignations in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990 (57 FR 13498) and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents:

7. “State Implementation Plan (SIP) Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS) On or After November 15, 1992,” Memorandum from Michael H. Shapiro, Acting Assistant Administrator for Air and Radiation, September 17, 1993;

10. “Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard,” Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, May 10, 1995.

IV. What is EPA's analysis of Missouri's redesignation request?A. Criteria (1)—The St. Louis Area Has Attained the 2008-Hour Ozone NAAQS

For redesignation of a nonattainment area to attainment, the CAA section 107(d)(3)(E)(i) requires EPA to determine that the area has attained the applicable NAAQS. An area is attaining the 2008 ozone NAAQS if it meets the 2008 ozone NAAQS, as determined in accordance with 40 CFR 50.15 and appendix P of part 50, based on three complete, consecutive calendar years of quality assured air quality data for all monitoring sites in the area. To attain the NAAQS, the three-year average of the annual fourth-highest daily maximum 8-hour average ozone concentrations (ozone design values) at each monitor must not exceed 0.075 ppm. The air quality data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in EPA's Air Quality System (AQS). Ambient air quality monitoring data for the three year period must also meet data completeness requirements. An ozone design value is valid if daily maximum 8-hour average concentrations are available for at least 90 percent of the days within the ozone monitoring seasons,2 on average, for the three-year period, with a minimum data completeness of 75 percent during the ozone monitoring season of any year during the three year period. See section 2.3 of appendix P to 40 CFR part 50.

2 The ozone season is defined by state in 40 CFR 58 appendix D. The ozone season for the St. Louis area runs from March-October.

On June 27, 2016, in accordance with CAA section 181(b)(2)(A) and the provisions of the SIP Requirements Rule, EPA determined that the St. Louis area attained the 2008 ozone NAAQS by its July 20, 2016, attainment date. See 81 FR 41444. EPA's determination was based upon three years of complete, quality assured and certified data that had been recorded in AQS for the 2013-2015 time period. The data demonstrated that the St. Louis area is attaining the 2008 ozone NAAQS. The annual fourth-highest 8-hour ozone concentrations and the three-year average of these concentrations (monitoring site ozone design values) for each monitoring site are summarized in table 1.

The most recent certified, quality assured data for 2017 indicates that the area continues to attain the 2008 ozone NAAQS. If the design value of a monitoring site in the area exceeds the NAAQS after proposal, but before final approval of the redesignation, EPA will not take final action to approve the redesignation of the St. Louis area to attainment.

The three-year ozone design value for 2013-2015 is 0.071 ppm,3 which meets the 2008 ozone NAAQS. Therefore, in this action, EPA proposes to determine that the St. Louis area is attaining the 2008 ozone NAAQS.

3 The ozone design value for the monitor with the highest three-year averaged concentration.

B. Criteria (2)—Missouri Has a Fully Approved SIP Under Section 110(k) for the St. Louis Area; and Criteria (5)—Missouri Has Met All Applicable Requirements for the St. Louis Area of Section 110 and Part D of the CAA

As criteria for redesignation of an area from nonattainment to attainment of a NAAQS, the CAA requires EPA to determine that the state has met all applicable requirements under CAA section 110 and part D of title I of the CAA (see section 107(d)(3)(E)(v) of the CAA) and that the state has a fully approved SIP under CAA section 110(k) (see section 107(d)(3)(E)(ii) of the CAA). EPA proposes to find that Missouri has met all currently applicable SIP requirements for purposes of redesignation of the St. Louis area to attainment of the 2008 ozone standard under section 110 and part D of the CAA in accordance with section 107(d)(2)(E)(v). In making these proposed determinations, EPA ascertained which CAA requirements are applicable to the St. Louis area and the Missouri SIP and, if applicable, whether the required Missouri SIP elements are fully approved under section 110(k) and part D of the CAA. As discussed more fully below, SIPs must be fully approved only with respect to currently applicable requirements of the CAA.4

1. Missouri Has Met All Applicable Requirements of Section 110 and Part D of the CAA Applicable to the Missouri Portion of the St. Louis Area for Purposes of Redesignation

General SIP Requirements. Section 110(a)(2) of the CAA delineates the general requirements for a SIP. Section 110(a)(2) provides that the SIP must have been adopted by the state after reasonable public notice and hearing, and that, among other things, it must: (1) Include enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; (2) provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to monitor ambient air quality; (3) provide for implementation of a source permit program to regulate the modification and construction of stationary sources within the areas covered by the plan; (4) include provisions for the implementation of part C prevention of significant deterioration (PSD) and part D new source review (NSR) permit programs; (5) include provisions for stationary source emission control measures, monitoring, and reporting; (6) include provisions for air quality modeling; and, (7) provide for public and local agency participation in planning and emission control rule development.

Section 110(a)(2)(D) of the CAA requires SIPs to contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address transport of certain air pollutants.5 However, like many of the 110(a)(2) requirements, the section 110(a)(2)(D) SIP requirement is not linked with a particular area's ozone designation and classification. EPA believes that the SIP requirements linked with the area's ozone designation and classification are the relevant measures to evaluate when reviewing a redesignation request for the area. The section 110(a)(2)(D) requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area within the state. Thus, EPA does not believe these requirements should be construed to be applicable requirements for the purposes of redesignation.6

5 Nitrogen oxides (NOX) are precursor pollutants to ozone formation. On October 27, 1992 (63 FR 57356), EPA issued a NOX SIP call requiring 22 states and the District of Columbia to reduce emissions of NOX in order to reduce the transport of ozone and ozone precursors.

In addition, EPA believes that other section 110 elements are neither connected with nonattainment plan submissions, nor linked with an area's ozone attainment status and are not applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated to attainment for the 2008 ozone NAAQS. The section 110 and part D requirements which are linked with a particular area's designation and classification are the relevant measures to evaluate when reviewing a redesignation request. This approach is consistent with EPA's existing policy on applicability (i.e., for redesignations) of conformity and oxygenated fuels requirements, as well as with section 184 ozone transport requirements.7 EPA has reviewed Missouri's SIP revision and has concluded that it meets the general SIP requirements under section 110 of the CAA to the extent that those requirements are applicable for purposes of redesignation. On March 22, 2018 (83 FR 12496), EPA approved elements of the SIP submitted by Missouri to meet the requirements of section 110 for the 2008 ozone standard. The requirements of section 110(a)(2), however, are statewide requirements that are not linked to the ozone nonattainment status of the St. Louis area. Therefore, EPA concludes that these infrastructure requirements are not applicable requirements for purposes of review of the state's ozone redesignation request.

Part D Requirements. Section 172(c) of the CAA sets forth the basic requirements of air quality plans for states with nonattainment areas that are required to submit them pursuant to section 172(b). Subpart 2 of part D, which includes section 182 of the CAA, establishes specific requirements for ozone nonattainment areas depending on the areas' nonattainment classifications.

The Missouri portion of the St. Louis area was classified as marginal under subpart 2 for the 2008 ozone NAAQS. As such, the area is subject to the subpart 1 requirements contained in section 172(c) and section 176. Similarly, the area is subject to the subpart 2 requirements contained in section 182(a) (marginal nonattainment area requirements). A thorough discussion of the requirements contained in section 172(c) and 182 can be found in the General Preamble for Implementation of title I (57 FR 13498).

Subpart 1 Section 172 Requirements. As provided in subpart 2, for marginal ozone nonattainment areas such as the St. Louis area, the specific requirements of section 182(a) apply in lieu of the attainment planning requirements that would otherwise apply under section 172(c), including the attainment demonstration and reasonably available control measures (RACM) under section 172(c)(1), reasonable further progress (RFP) under section 172(c)(2), and contingency measures under section 172(c)(9).8

8See 42 U.S.C. 7511a(a).

Section 172(c)(3) requires submission and approval of a comprehensive, accurate and current inventory of actual emissions. This requirement is superseded by the inventory requirement in section 182(a)(1) discussed below.

Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified stationary sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area. EPA most recently approved Missouri's NSR program on June 4, 2015 (80 FR 31844).9 EPA has determined that, since PSD requirements will apply after redesignation, areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR. A more detailed rationale for this view is described in the Nichols Memorandum. See also rulemakings for the Illinois portion of the St. Louis Area (77 FR 34819, 77 FR 34826, June 12, 2012); Louisville, Kentucky (66 FR 53665, 66 FR 53669, October 23, 2001); Grand Rapids, Michigan (61 FR 31831, 61 FR 31834-61 FR 31837, June 21, 1996); Cleveland-Akron-Lorain, Ohio (61 FR 20458, 61 FR 20469-61 FR 20470, May 7, 1996); Detroit, Michigan (60 FR 12459, 61 FR 12467-61 FR 12468, March 7, 1995). Missouri has demonstrated that the area will be able to maintain the standard without part D NSR in effect; therefore, EPA concludes that the state need not have a fully approved part D NSR program prior to approval of the redesignation request. Missouri's PSD program will become effective in the area upon redesignation to attainment.

9 The “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” submitted by the state on September 9, 2014 noted that the state's NSR program was approved by EPA and that no “corrections” needed to be made in the SIP. This SIP revision was approved on February 25, 2016 (81 FR 9346).

Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the NAAQS. Because attainment has been reached, no additional measures are needed to provide for attainment.

Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted above, we believe the Missouri SIP meets the requirements of section 110(a)(2) for purposes of redesignation.

Subpart 1 Section 176 Conformity Requirements. Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that Federally supported or funded projects conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs and projects that are developed, funded or approved under title 23 of the United States Code (U.S.C.) and the Federal Transit Act (transportation conformity) as well as to all other Federally supported or funded projects (general conformity). State transportation conformity SIP revisions must be consistent with Federal conformity regulations relating to consultation, enforcement and enforceability that EPA promulgated pursuant to its authority under the CAA.

EPA interprets the conformity SIP requirements as not applying for purposes of evaluating a redesignation request under section 107(d) because state conformity rules are still required after redesignation and Federal conformity rules apply where state conformity rules have not been approved.10See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001) (upholding this interpretation); see also 60 FR 62748 (December 7, 1995) (redesignation of Tampa, Florida). Nevertheless, Missouri has an approved conformity SIP for the St. Louis-St. Charles-Farmington, MO-IL area. See 78 FR 53247 (August 29, 2013).

10 CAA section 176(c)(4)(E) requires states to submit revisions to their SIPs to reflect certain Federal criteria and procedures for determining transportation conformity. Transportation conformity SIPs are different from SIPs requiring the development of Motor Vehicle Emission Budgets (MVEBs), such as control strategy SIPs and maintenance plans.

Section 182(a) Requirements. Section 182(a)(1) requires states to submit a comprehensive, accurate, and current inventory of actual emissions from sources of volatile organic compounds (VOCs) and nitrogen oxides (NOX) emitted within the boundaries of the ozone nonattainment area. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” submitted by the state on September 9, 2014, included a 2011 base year emissions inventory for the Missouri portion of the St. Louis area. EPA approved this emissions inventory as a revision to the Missouri SIP on February 25, 2016 (81 FR 9346).

Under section 182(a)(2)(A), states with ozone nonattainment areas that were designated before the enactment of the 1990 CAA amendments were required to submit, within six months of classification, all rules and corrections to existing VOC reasonably available control technology (RACT) rules that were required under section 172(b)(3) before the 1990 CAA amendments. The St. Louis area is not subject to the section 182(a)(2) RACT “fix up” requirement for the 2008 ozone NAAQS because it was designated as nonattainment for this standard after the enactment of the 1990 CAA amendments and because Missouri complied with this requirement for the St. Louis area under the prior 1-hour ozone NAAQS.11

11See 65 FR 31482 (June 18, 2000) and 61 FR 10968 (March 18, 1996).

Section 182(a)(2)(B) requires each state with a marginal ozone nonattainment area that implemented or was required to implement a vehicle inspection and maintenance (I/M) program before the 1990 CAA amendments to submit a SIP revision for an I/M program no less stringent than that required prior to the 1990 CAA amendments or already in the SIP at the time of the CAA amendments, whichever is more stringent. For the purposes of the 2008 ozone standard and the consideration of Missouri's redesignation request for this standard, the St. Louis area is not subject to the section 182(a)(2)(B) requirement because the St. Louis area was designated as nonattainment for the 2008 ozone standard after the enactment of the 1990 CAA amendments.

Regarding the source permitting and offset requirements of section 182(a)(2)(C) and section 182(a)(4), as previously noted, Missouri currently has a fully-approved part D NSR program in place. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” submitted in September 2014, included an offset ratio. As noted in the September 2014 SIP revision, the requirement for emission offset reductions is part of Missouri's NSR program and codified in the state's regulations at 10 CSR 10-6.060(7)(B)1. The corresponding offset ratio for each ozone area classification (i.e. 1.1:1 for Marginal) is found in the Federal code at 40 CFR 51.165(a)(3)(9). Thus Missouri has satisfied the CAA section 182(a)(4) requirement for Marginal Area Plan submissions in establishing a Marginal Area emission offset reduction ratio of 1.1:1 in its NSR program by SIP-approved rule consistent with the corresponding Federal code. EPA approved the September 2014 SIP revision on February 25, 2016 (81 FR 9346).

Section 182(a)(3) requires states to submit periodic emission inventories and a revision to the SIP to require the owners or operators of stationary sources to annually submit emission statements documenting actual VOC and NOX emissions. As discussed below, Missouri will continue to update its emissions inventory at least once every three years. With regard to stationary source emission statements, EPA last approved Missouri's emission statement rule on March 19, 2015 (80 FR 14312). In MDNR's May 22, 2015 submittal, Missouri stated that this approved SIP regulation remains in place and remains enforceable for the 2008 ozone standard. The state's “Marginal Area Plan for the Missouri Portion of the St. Louis Nonattainment Area for the 2008 8-Hour Ground Level Ozone National Ambient Air Quality Standard” SIP revision submitted in September 2014, noted that SIP approved state regulation 10 CSR 10-6.110 Reporting Emission Data, Emission Fees, and Process Information requires permitted sources to file an annual report on air pollutant emissions to include emissions data, process information, and annual emissions fees. EPA approved the September 2014 SIP revision on February 25, 2016 (81 FR 9346).

EPA is proposing to approve that the Missouri portion of the St. Louis area has satisfied all applicable requirements for purposes of redesignation under section 110 and part D of title I of the CAA.

2. The St. Louis Area Has a Fully Approved SIP for Purposes of Redesignation Under Section 110(k) of the CAA

As discussed above, EPA has fully approved the Missouri SIP for the St. Louis area under section 110(k) all requirements applicable for purposes of redesignation under the 2008 ozone NAAQS. EPA may rely on prior SIP approvals in approving a redesignation request (see the Calcagni memorandum at page 3; Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d 984, 989-90 (6th Cir. 1998); Wall v. EPA, 265 F.3d 426), plus any additional measures it may approve in conjunction with a redesignation action (see 68 FR 25426 (May 12, 2003) and citations therein). Missouri has adopted and submitted, and EPA has fully approved at various times, provisions addressing the various SIP elements applicable for the ozone NAAQS.

As indicated above, EPA believes that the section 110 elements that are neither connected with nonattainment plan submissions nor linked to an area's nonattainment status are not applicable requirements for purposes of redesignation. EPA has approved all part D requirements applicable for purposes of this redesignation.

C. Criteria (3)—The Air Quality Improvement in the St. Louis Area Is Due to Permanent and Enforceable Emission Reductions

To support the redesignation of an area from nonattainment to attainment, section 107(d)(3)(E)(iii) of the CAA requires EPA to determine that the air quality improvement in the area is due to permanent and enforceable reductions in emissions resulting from the implementation of the SIP and applicable Federal air pollution control regulations and other permanent and enforceable emission reductions. EPA is proposing to determine that Missouri has demonstrated that the observed ozone air quality improvement in the St. Louis area is due to permanent and enforceable reductions in VOC and NOX emissions resulting from state measures adopted into the SIP and Federal measures.

In making this demonstration, the state has calculated the change in emissions between 2011 and 2014. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that the St. Louis area and upwind areas have implemented in recent years. Based on the information summarized below, Missouri has adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.

Clean Air Interstate Rule (CAIR)/Cross State Air Pollution Rule (CSAPR)/CSAPR Update. CAIR created regional cap-and-trade programs to reduce sulfur dioxide (SO2) and NOX emissions in twenty seven eastern states, including Missouri, that contributed to downwind nonattainment and maintenance of the 1997 8-hour ozone NAAQS and the 1997 fine particulate matter (PM2.5) NAAQS. See 70 FR 25162 (May 12, 2005). EPA approved Missouri's CAIR regulations into the Missouri SIP on December 14, 2007 (72 FR 71073). In 2008, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) initially vacated CAIR, North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008), but ultimately remanded the rule to EPA without vacatur to preserve the environmental benefits provided by CAIR, North Carolina v. EPA, 550 F.3d 1176, 1178 (D.C. Cir. 2008). On August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's remand, EPA promulgated CSAPR to replace CAIR and thus to address the interstate transport of emissions contributing to nonattainment and interfering with maintenance of the two air quality standards covered by CAIR as well as the 2006 PM2.5 NAAQS. CSAPR requires substantial reductions of SO2 and NOX emissions from electric generating units (EGUs) in 28 states in the Eastern United States.

The D.C. Circuit's initial vacatur of CSAPR was reversed by the United States Supreme Court on April 29, 2014, and the case was remanded to the D.C. Circuit to resolve remaining issues in accordance with the high court's ruling. EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014).12 On remand, the D.C. Circuit affirmed CSAPR in most respects, but invalidated without vacating some of the CSAPR budgets as to a number of states. EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015). This litigation ultimately delayed implementation of CSAPR for three years, from January 1, 2012, when CSAPR's cap-and-trade programs were originally scheduled to replace the CAIR cap-and-trade programs, to January 1, 2015. Thus, the rule's Phase 2 budgets that were originally promulgated to begin on January 1, 2014, began on January 1, 2017.

On November 21, 2014, the Administrator signed an action that published in the Federal Register on December 3, 2014 (79 FR 71163), amending the regulatory text of CSAPR to reflect the Court's October 23, 2014, order tolling all deadlines in CSAPR by three years, including provisions governing the sunsetting of CAIR. CAIR therefore sunset at the end of 2014 and was replaced by CSAPR beginning January 1, 2015, which continue to remain in place. Relative to CAIR, CSAPR required similar or greater emission reductions from relevant upwind areas starting in 2015 and beyond, and Missouri's emissions budgets were not affected by the Court's remand of some of the ozone-season and SO2 budgets.

While the reduction in NOX emissions from the implementation of CSAPR will result in lower concentrations of transported ozone and ozone precursors entering the St. Louis area throughout the maintenance period, EPA is proposing to approve the redesignation of the St. Louis area without relying on those measures within Missouri as having led to attainment of the 2008 ozone NAAQS or contributing to maintenance of that standard because, as noted above, CSAPR did not go into effect until January 1, 2015. As a general matter, EPA expects that the implementation of CSAPR will preserve the reductions achieved by CAIR and result in additional SO2 and NOX emission reductions throughout the maintenance period.

In addition, on October 26, 2016 (81 FR 74504), EPA finalized the Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS (CSAPR Update). This new rule replaces the CSAPR rule for purposes of transport of ozone pollution with respect to the 2008 ozone NAAQS. The finalized rule issued a Federal Implementation Plan (FIP) that generally provided updated CSAPR NOX ozone season emission budgets for the EGUs within twenty two states in the eastern United States, and implements these budgets via modifications to the CSAPR NOX ozone season allowance trading program established under the original CSAPR. The CSAPR Update rule became effective on December 27, 2016.

b. Federal and State Emission Control Measures

Reductions in VOC and NOX emissions have occurred statewide and in upwind areas as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures are described below.

Tier 2 Emission Standards for Vehicles and Gasoline Sulfur Standards. On February 10, 2000 (65 FR 6698), EPA promulgated Tier 2 motor vehicle emission standards and gasoline sulfur control requirements. These emission control requirements result in lower VOC and NOX emissions from new cars and light duty trucks, including sport utility vehicles. With respect to fuels, this rule required refiners and importers of gasoline to meet lower standards for sulfur in gasoline, which were phased in between 2004 and 2006. By 2006, refiners were required to meet a 30 ppm average sulfur level, with a maximum cap of 80 ppm. This reduction in fuel sulfur content ensures the effectiveness of low emission-control technologies. The Tier 2 tailpipe standards established in this rule were phased in for new vehicles between 2004 and 2009. EPA estimates that, when fully implemented, this rule will cut NOX and VOC emissions from light-duty vehicles and light-duty trucks by approximately 76 and 28 percent, respectively. NOX and VOC reductions from medium-duty passenger vehicles included as part of the Tier 2 vehicle program are estimated to be approximately 37,000 and 9,500 tons per year, respectively, when fully implemented. In addition, EPA estimates that beginning in 2007, a reduction of 30,000 tons per year of NOX will result from the benefits of sulfur control on heavy-duty gasoline vehicles. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period, as older vehicles are replaced with newer, compliant model years.

Heavy-Duty Diesel Engine Rules. In July 2000, EPA issued a rule for on-highway heavy-duty diesel engines that includes standards limiting the sulfur content of diesel fuel. Emissions standards for NOX, VOC and PM were phased in between model years 2007 and 2010. In addition, the rule reduced the highway diesel fuel sulfur content to 15 parts per million by 2007, leading to additional reductions in combustion NOX and VOC emissions. EPA has estimated future year emission reductions due to implementation of this rulemaking. Nationally, EPA estimated that 2015 NOX and VOC emissions would decrease by 1,260,000 tons and 54,000 tons, respectively. Nationally, EPA estimated that 2030 NOX and VOC emissions will decrease by 2,570,000 tons and 115,000 tons, respectively.

Nonroad Diesel Rule. On June 29, 2004 (69 FR 38958), EPA issued a rule adopting emissions standards for nonroad diesel engines and sulfur reductions in nonroad diesel fuel. This rule applies to diesel engines used primarily in construction, agricultural, and industrial applications. The rule is being phased between 2008 through 2015, and when fully implemented will reduce emissions of NOX, VOC, particulate matter, and carbon monoxide from these engines. It is estimated that compliance with this rule will cut NOX emissions from these nonroad diesel engines by approximately 90 percent nationwide.

Nonroad Spark-Ignition Engines and Recreational Engine Standards. On November 8, 2002 (67 FR 68242), EPA adopted emission standards for large spark-ignition engines such as those used in forklifts and airport ground-service equipment; recreational vehicles such as off-highway motorcycles, all-terrain vehicles, and snowmobiles; and recreational marine diesel engines. These emission standards are phased in from model year 2004 through 2012. When fully implemented, EPA estimates an overall 72 percent reduction in VOC emissions from these engines and an 80 percent reduction in NOX emissions. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period.

National Emission Standards for Hazardous Air Pollutants (NESHAP) for Reciprocating Internal Combustion Engines. On March 3, 2010 (75 FR 9684), EPA issued a rule to reduce hazardous air pollutants from existing diesel powered stationary reciprocating internal combustion engines, also known as compression ignition engines. Amendments to this rule were finalized on January 14, 2013 (78 FR 6674). EPA estimated that when this rule was fully implemented in 2013, NOX and VOC emissions from these engines would be reduced by approximately 9,600 and 36,000 tons per year, respectively.

Category 3 Marine Diesel Engine Standards. On April 30, 2010 (75 FR 22896), EPA issued emission standards for marine compression-ignition engines at or above 30 liters per cylinder. Tier 2 emission standards apply beginning in 2011, and are expected to result in a 15 to 25 percent reduction in NOX emissions from these engines. Final Tier 3 emission standards apply beginning in 2016 and are expected to result in approximately an 80 percent reduction in NOX from these engines. Some of these emission reductions occurred by the attainment years and additional emission reductions will occur throughout the maintenance period.

c. Control Measures Specific to the St. Louis Area

Gateway Vehicle Inspection Program. On March 3, 2015 (80 FR 11323), EPA approved Missouri's Gateway Vehicle Inspection Program which is found in the Missouri Code of State Regulation (CSR) at 10 CSR 5.381. This regulation is permanent and enforceable, and will result in continued significant reductions in both NOX and VOC emissions from 2014 to 2030.

2. Emission Reductions

Missouri is using a 2011 emissions inventory as the nonattainment base year. Area, nonroad mobile, onroad mobile, and point source emissions (EGUs and non-EGUs) were collected from the Ozone NAAQS Implementation Modeling platform (2011v6.1). MDNR also provided an emissions inventory for wildfires (Event) and biogenic sources. For 2011, this represents actual data Missouri reported to EPA for the 2011 National Emissions Inventory (NEI). Because emissions from state inventory databases, the NEI, and the Ozone NAAQS Emissions Modeling platform are annual totals, tons per summer day (tpd) were derived according to EPA's guidance document “Temporal Allocation of Annual Emissions Using EMCH Temporal Profiles” dated April 29, 2002, using the temporal allocation references accompanying the 2011v6.1 modeling inventory files.

For the attainment inventory, Missouri used 2014, one of the years the St. Louis area monitored attainment of the 2008 ozone standard. Because the 2014 NEI inventory was not available at the time MDNR was compiling the redesignation request, the state was unable to use the 2014 NEI inventory directly. For area, nonroad mobile, wildfire, and biogenic sources, 2014 emissions were derived by interpolating between 2011 and 2018 Ozone NAAQS Emissions Modeling platform inventories. The point source sector for the 2014 inventory was developed using actual 2014 point source emissions reported to the state database, which serve as the basis for the point source emissions reported to EPA for the NEI. Summer day inventories were derived for these sectors using the methodology described above. Finally, onroad mobile source emissions were developed using the same methodology described above for the 2011 inventory.

Using the inventories described above, Missouri's submittal documents changes in VOC and NOX emissions from 2011 to 2014 for the Missouri portion of the St. Louis area. Emissions data are shown in tables 2 through 6.

Table 2—Missouri Portion of the St. Louis Area NOX Emissions for Nonattainment Year 2011 [tpd]CountyPointAreaOnroadNonroadFranklin27.750.497.835.72Jefferson16.660.6212.453.33St. Charles25.040.6821.048.34St. Louis16.742.6566.3423.85St. Louis City4.491.1616.556.31Total90.685.60124.2147.55Table 3—Missouri Portion of the St. Louis Area VOC Emissions for Nonattainment Year 2011[tpd]CountyPointAreaOnroadNonroadFranklin2.523.362.43.31Jefferson1.637.484.243.12St. Charles3.3411.216.736.23St. Louis3.538.6820.1722.99St. Louis City3.5912.044.463.38Total14.5872.7738.0039.03Table 4—Missouri Portion of the St. Louis Area NOX Emissions for Attainment Year 2014 [tpd]CountyPointAreaOnroadNonroadFranklin21.130.468.005.24Jefferson17.960.4212.873.04St. Charles21.050.8919.687.40St. Louis16.793.7760.2917.53St. Louis City4.780.9310.925.23Total81.716.47111.7638.44Table 5—Missouri Portion of the St. Louis Area VOC Emissions for Attainment Year 2014 [tpd]CountyPointAreaOnroadNonroadFranklin2.085.802.572.91Jefferson1.915.444.652.72St. Charles4.1211.507.755.25St. Louis2.8735.8819.0119.61St. Louis City2.8811.194.232.92Total13.8669.8138.2133.42Table 6—Change in NOX and VOC Emissions in the Missouri Portion of the St. Louis Area Between 2011 and 2014 [tpd]NOX20112014Net changeVOC20112014Net changePoint90.6881.70−8.9814.5813.86−0.72Area5.606.470.8772.7769.81−2.96Onroad124.21111.76−12.4538.0038.210.21Nonroad47.5538.44−9.1139.0333.42−5.61Total268.04238.37−29.67164.38155.30−9.08

As indicated in table 6, total NOX and VOC emissions decreased by nearly 30 and 9 tpd respectively from the base year to the attainment year.13 Based on the control measures identified above in conjuction with the emission reductions, Missouri has adequately deomonstrated that the improvement in air quality is due to permanent and enforceable emission reductions.

13 In a letter submitted by MDNR and received by EPA August 7, 2017, the state provided clarifying information on NOx and VOC emissions. This letter and the original submission can be found in the docket for this action.

D. Criteria (4)—The Area Has a Fully Approvable Ozone Maintenance Plan Pursant to Section 175 of the CAA

As one of the criteria for redesignation to attainment, section 107(d)(3)(E)(iv) of the CAA requires EPA to determine that the area has a fully approved maintenance plan pursuant to section 175A of the CAA. Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the maintenance plan must demonstrate continued attainment of the NAAQS for at least ten years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the state must submit a revised maintenance plan which demonstrates that attainment of the NAAQS will continue for an additional ten years beyond the initial ten year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures, as EPA deems necessary, to assure prompt correction of the future NAAQS violation.

In conjunction with its request to redesignate the Missouri portion of the St. Louis area to attainment for the 2008 ozone standard, MDNR submitted a SIP revision to provide for maintenance of the 2008 ozone standard through 2030, more than ten years after the expected effective date of the redesignation to attainment. As discussed below, EPA is proposing that this maintenance plan meets the requirements for approval under section 175A of the CAA.

The Calcagni Memorandum provides further guidance on the content of a maintenance plan, explaining that a maintenance plan should address five elements: (1) An attainment emission inventory; (2) a maintenance demonstration; (3) a commitment for continued air quality monitoring; (4) a process for verification of continued attainment; and (5) a contingency plan. EPA is proposing to find that Missouri's ozone maintenance plan includes these necessary components and, as part of this action, is proposing to approve the maintenance plan as a revision of the Missouri SIP.

1. Attainment Emissions Inventory

EPA is proposing to determine that the St. Louis area has attained the 2008 ozone NAAQS based on monitoring data for the period of 2013-2015. As previously stated, MDNR selected 2014 as the attainment emissions inventory year to establish attainment emission levels for NOX and VOC. The attainment emissions inventory identifies the levels of emissions in the Missouri portion of the St. Louis area that are sufficient to attain the 2008 ozone NAAQS. The derivation of the attainment year emissions is discussed above in section IV of this proposed rule. The attainment level emissions, by source category, are summarized in tables 4 and 5.

2. Maintenance Demonstration

Missouri has demonstrated maintenance of the 2008 ozone standard through 2030 by assuring that current and future emissions of VOC and NOX for the St. Louis area remain at or below attainment year emission levels. A maintenance demonstration does not need to be based on modeling.14

Missouri used emissions for the 2014 year as a baseline and compared them to projected emissions for 2020 and 2030 to demonstrate maintenance. The year 2030 is more than ten years after the expected effective date of the redesignation to attainment and the year 2020 was selected to demonstrate that emissions are not expected to spike in the interim between the attainment year and the final maintenance year. The emissions inventories were developed as described below.

For point, area, and nonroad emissions inventory development, Missouri estimated 2030 emissions by using the 2014 base year inventory and applying growth factors appropriate for each source category. For area sources, Stage II refueling emissions were calculated using MOVES and assumed that Stage II vehicle refueling vapor recovery controls would no longer be required by 2030.15

15 Missouri developed and submitted a SIP revision to remove Stage II vapor recovery requirements in the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL area. EPA approved the revision and the action became effective on December 10, 2015. See 80 FR 69602.

For non-EGU and nonpoint emissions inventory development, Missouri collected data from the 2011NEIv2-based platform (2011v6.2) inventories for years 2011, 2017, and 2025. Missouri then calculated growth factors for years 2017 and 2025 by dividing 2011 annual emissions by 2017 and 2025 annual emissions. Then, to estimate 2020 and 2030 growth factors, the program interpolated the 2017 and 2025 growth factors and then extrapolated to 2030. Missouri then used the TREND function in Excel to obtain data for 2026-2030. Summer day inventories were derived for these sectors using the methodology described above.

For EGU emissions, Missouri decided to use 2011v6.2 emissions from 2017 for 2020 and emissions from 2025 for 2030 because MDNR believes that it was not appropriate to use the same growth methodology for non-EGUs and EGUs, as growth in the EGU sector depends on energy demand and environmental, transmission, dispatch, and reliability constraints.

Finally, onroad mobile source emissions were developed using EPA's MOVES program with Vehicle Miles Traveled (VMT) data gathered from the East-West Gateway Council of Governments (EWGW) in coordination with the St. Louis Transportation Conformity Interagency Consultation Group. Missouri specifically used MOVES version 2014a-20151201 as it was the latest release at the time of inventory development. In developing the future year inventories, Missouri developed several future year model input tables, specifically age distribution, VMT, and vehicle population tables for 2020 and 2030. These input tables were developed with the help of MODOT, the Federal Highway Administration, and the EWGW. The emissions data for 2020 and 2030 is shown below in tables 7 through 11.

Table 7—Missouri Portion of the St. Louis Area NOX Emissions for Interim Maintenance Year 2020 [tpd]CountyPointAreaOnroadNonroadFranklin30.923.115.994.03Jefferson23.581.184.992.19St. Charles8.822.417.895.28St. Louis21.196.3723.6012.65St. Louis City4.093.793.954.13Total88.616.8746.4228.27Table 8—Missouri Portion of the St. Louis Area VOC Emissions for Interim Maintenance Year 2020[tpd]CountyPointAreaOnroadNonroadFranklin2.505.877.892.06Jefferson1.755.382.412.17St. Charles4.1711.393.904.21St. Louis3.0635.0310.4717.84St. Louis City2.8411.161.972.44Total14.3268.8626.6428.71Table 9—Missouri Portion of the St. Louis Area NOX Emissions for Interim Maintenance Year 2030[tpd]CountyPointAreaOnroadNonroadFranklin30.922.203.221.97Jefferson27.720.882.732.32St. Charles8.871.814.345.88St. Louis21.755.4413.1016.93St. Louis City3.822.702.182.80Total93.0813.0325.5729.90Table 10—Missouri Portion of the St. Louis Area VOC Emissions for Interim Maintenance Year 2030[tpd]CountyPointAreaOnroadNonroadFranklin2.325.825.451.79Jefferson1.965.381.702.13St. Charles4.1711.382.724.04St. Louis3.0835.117.2119.45St. Louis City2.7811.121.342.60Total14.3168.8018.4230.01Table 11—Change in NOX and VOC Emissions in the Missouri Portion of the St. Louis Area Between 2014 and 2030 [tpd]NOX201420202030Net change

In summary, the maintenance demonstration for the Missouri portion of the St. Louis area demonstrates maintenance of the 2008 ozone standard. It does so by providing emissions information that future emissions of NOX and VOC will remain at or below 2014 emission levels when taking into account both future source growth and implementation of future controls.

Table 11 shows NOX and VOC emissions in the Missouri portion of the St. Louis area are projected to decrease by 76.79 tpd and 23.76 tpd, respectively, between 2014 and 2030.

In addition, since the St. Louis area covers both Missouri and Illinois, MDNR provided data from the Illinois portion of the St. Louis area. This data is summarized below in table 12 and shows that the Illinois portion of the St. Louis area will also show decreases in NOX and VOC emissions from 2014 to 2030. This data is provided here for informational purposes only as the EPA is not proposing to redesignate the Illinois portion of the St. Louis area in this action.

Table 12—Change in NOX and VOC Emissions in the Illinois Portion of the St. Louis-St. Charles-Farmington, MO-IL Area Between 2014 and 2030[tpd]NOX201420202030Net change

(2014-2030)

VOC201420202030Net change

(2014-2030)

Point23.2916.8116.93−6.369.389.038.53−0.84Area1.531.511.51−0.0219.0618.3918.05−1.00Onroad26.9413.226.71−20.2410.116.383.76−6.36Nonroad24.6218.4411.31−13.317.475.655.09−2.38Total76.3849.9836.46−39.9346.0239.4535.43−10.583. Continued Air Quality Monitoring

MDNR has committed to continue to operate the ozone monitors listed in table 1 above and has committed to consult with the EPA prior to making changes to the existing monitoring network should changes become necessary in the future. Missouri remains obligated to meet monitoring requirements and continue to quality assure monitoring data in accordance with 40 CFR part 58, and to enter all data into the Air Quality System (AQS) in accordance with Federal guidelines. EPA approved Missouri's monitoring plan on December 19, 2017. See https://www.epa.gov/mo/region-7-states-air-quality-monitoring-plans-missouri.

4. Verification of Continued Attainment

The State of Missouri has the legal authority to enforce and implement the requirements of the maintenance plan for the Missouri portion of the St. Louis area. This includes the authority to adopt, implement, and enforce any subsequent emission control measures determined to be necessary to correct future ozone attainment problems.

Verification of continued attainment is accomplished through operation of the ambient ozone monitoring network and the periodic update of the area's emissions inventory. MDNR will continue to operate the current ozone monitors located in the Missouri portion of the St. Louis area. There are no plans to discontinue operation, relocate, or otherwise change the existing ozone monitoring network other than through revisions in the network approved by the EPA.16

In addition, to track future levels of emissions, MDNR will continue to develop and submit to the EPA updated emission inventories for all source categories at least once every three years, consistent with the requirements of 40 CFR part 51, subpart A, and in 40 CFR 51.122. The Consolidated Emissions Reporting Rule (CERR) was promulgated by EPA on June 10, 2002 (67 FR 39602). The CERR was replaced by the Annual Emissions Reporting Requirements (AERR) on December 17, 2008 (73 FR 76539). The most recent triennial inventory for Missouri was compiled for 2014. Point source facilities are covered by Missouri's emission statement rule, 10 CSR 10-6.110 (Reporting Emission Data, Emission Fees, and Process Information), and they will continue to submit VOC and NOX emissions on an annual basis.

5. Contingency Measures in the Maintenance Plan

Section 175A of the CAA requires that the state must adopt a maintenance plan, as a SIP revision, that includes such contingency measures as the EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation of the area to attainment of the NAAQS. The maintenance plan must identify the following items: The contingency measures to be considered and, if needed for maintenance, adopted and implemented; a schedule and procedure for adoption and implementation; and, a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be considered, adopted, and implemented. The maintenance plan must include a commitment that the state will implement all measures with respect to the control of the pollutant that were contained in the SIP before redesignation of the area to attainment in accordance with section 175A(d) of the CAA.

As required by section 175A of the CAA, Missouri has adopted a contingency plan for the Missouri portion of the St. Louis area to address possible future ozone air quality problems. The contingency plan adopted by Missouri has two levels of response, a warning level response and an action level response.

In Missouri's plan, a Level I warning would occur if the fourth highest 8-hour ozone concentration at any monitoring site in the maintenance area (including sites in Missouri and Illinois) exceeds 0.079 ppm in any year. A warning level response will consist of Missouri conducting a study to determine whether the ozone value indicates a trend toward higher ozone values or whether emissions appear to be increasing. The study will evaluate whether the trend, if any, is likely to continue and, if so, the control measures necessary to reverse the trend. The evaluation will be completed as expeditiously as possible, but no later than twenty-four months after MDNR has determined that a Level I trigger has occurred.

In Missouri's plan, an action Level II response is triggered when a violation (based on the average of the last three (3) years' 4th highest maximum daily 8-hour average concentrations (40 CFR 50.15)) of the NAAQS at any monitoring station in the maintenance area occurs. When an action level response is triggered, MDNR will conduct an analysis to determine the appropriate measures to address the cause of the violation. This analysis will be completed within six months of the violation. Selected measures will be implemented as expeditiously as practicable, taking into consideration the ease of implementation and the technical and economic feasibility of the selected measure. The state committed to the implementation of contingency measures, under Level I or Level II triggers, taking place as expeditiously as practicable, but in no event later than twenty-four months after the state makes a determination that a trigger has occurred, based on quality-assured ambient data that has been entered into AQS. Missouri included the following list of potential contingency measures in its maintenance plan:

• Update 10 CSR 10-6.130 (Controlling Emissions During Episodes of High Air Pollution Potential), specifically: Lowering the alert/action trigger levels, amending the rule to require alert/action level abatement plans at more facilities, and requiring existing abatement plans to be amended with more current emission reduction measures;

EPA has concluded that the maintenance plan adequately addresses the five basic components of a maintenance plan: An attainment emission inventory, a maintenance demonstration, continued air quality monitoring, verification of continued attainment, and a contingency plan. In addition, as required by section 175A(b) of the CAA, the state has committed to submit to the EPA an updated ozone maintenance plan eight years after redesignation of the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL area to cover an additional ten years beyond the initial ten-year maintenance period. Thus, the maintenance plan SIP revision submitted by MDNR for the Missouri portion of the St. Louis area meets the requirements of section 175A of the CAA, EPA proposes to approve it as a revision to the Missouri SIP.

Under section 176(c) of the CAA, new transportation plans, programs, or projects that receive Federal funding or support, such as the construction of new highways, must “conform” to (i.e., be consistent with) the SIP. Conformity to the SIP means that transportation activities will not cause new air quality violations, worsen existing air quality problems, or delay timely attainment of the NAAQS or interim air quality milestones. Regulations at 40 CFR part 93 set forth the EPA policy, criteria, and procedures for demonstrating and assuring conformity of transportation activities to a SIP. Transportation conformity is a requirement for nonattainment and maintenance areas. Maintenance areas are areas that were previously nonattainment for a particular NAAQS, but that have been redesignated to attainment with an approved maintenance plan for the NAAQS.

Under the CAA, states are required to submit, at various times, control strategy SIPs for nonattainment areas and maintenance plans for areas seeking redesignations to attainment of the ozone standard and maintenance areas.17 These control strategy SIPs (including reasonable further progress plans and attainment plans) and maintenance plans must include MVEBs for criteria pollutants, including ozone, and their precursor pollutants (VOC and NOX for ozone) to address pollution from onroad transportation sources. The MVEBs are the portion of the total allowable emissions that are allocated to highway and transit vehicle use that, together with emissions from other sources in the area, will provide for attainment or maintenance.18

17See the SIP requirements for the 2008 ozone standard in the EPA's March 6, 2015 implementation rule (80 FR 12264).

18See 40 CFR 93.101.

Under 40 CFR part 93, a MVEB for an area seeking a redesignation to attainment must be established, at minimum, for the last year of the maintenance plan; a state may adopt MVEBs for other years as well. The MVEB serves as a ceiling on emissions from an area's planned transportation system and is further explained in the preamble to the November 24, 1993, Transportation Conformity Rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and how to revise the MVEB, if needed, subsequent to initially establishing a MVEB in the SIP.

B. What is the status of the EPA's adequacy determination for the proposed VOC and NOX MVEBs for the St. Louis area?

When reviewing submitted control strategy SIPs or maintenance plans containing MVEBs, the EPA must affirmatively find that the MVEBs contained therein are adequate for use in determining transportation conformity. Once EPA affirmatively finds that the submitted MVEBs are adequate for transportation purposes, the MVEBs must be used by state and Federal agencies in determining whether proposed transportation projects conform to the SIP as required by section 176(c) of the CAA.

EPA's substantive criteria for determining adequacy of a MVEB are set out at 40 CFR 93.118(e)(4). The process for determining adequacy consists of three basic steps: Public notification of a SIP submission; provision for a public comment period; and EPA's adequacy determination. This process for determining the adequacy of submitted MVEBs for transportation conformity purposes was initially outlined in EPA's May 14, 1999 guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” EPA adopted regulations to codify the adequacy process in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM2.5 National Ambient Air Quality Standards and Miscellaneous Revisions for Existing Areas; Transportation Conformity Rule Amendments—Response to Court Decision and Additional Rule Change,” on July 1, 2004 (69 FR 40004).

As discussed earlier, Missouri's maintenance plan includes NOX and VOC MVEBs for the Missouri portion of the St. Louis area for 2014 and 2030, the attainment level year and the last year of the maintenance period. EPA reviewed the VOC and NOX MVEBs with the adequacy process. Missouri's September 12, 2016 and February 16, 2018, maintenance plan SIP submissions, including the VOC and NOX MVEBs for the area, were open for public comment on EPA's adequacy website on April 10, 2018, at: https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity.

The EPA public comment period on adequacy of the 2030 MVEBs for the Missouri portion of the St. Louis area closed on May 10, 2018. No comments on the submittal were received during the adequacy comment period. The submitted maintenance plan, which included the MVEBs, was endorsed by the Governor's designee, was subject to a state public hearing, and was developed as part of an interagency consultation process which includes Federal, state, and local agencies. These MVEBs, when considered together with all other emissions sources, are consistent with maintenance of the 2008 8-hour ozone standard.

Table 13—MVEBs for the Missouri Portion of the St. Louis Area [tpd]Attainment year 2014 onroad emissions2030 estimated onroad emissions2030 mobile

safety margin

allocation

2030 MVEBsVOC38.2118.423.5822NOX111.7625.5714.4340

As shown in table 13, the 2030 MVEBs exceed the estimated 2030 onroad sector emissions. In an effort to accommodate future variations in travel demand models and vehicle miles traveled forecast, MDNR allocated a portion of the safety margin (described further below) to the mobile sector. Missouri has demonstrated that the Missouri portion of the St. Louis area can maintain the 2008 ozone NAAQS with mobile source emissions in the area of 22 tpd of VOC and 40 tpd of NOX in 2030, since despite partial allocation of the safety margin, emissions will remain under attainment year emission levels. Based on this analysis, the St. Louis area should maintain attainment of the 2008 ozone NAAQS for the relevant maintenance period with mobile source emissions at the levels of the MVEBs.

Therefore, EPA has found that the MVEBs are adequate and is proposing to approve the MVEBs for use in determining transportation conformity in the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL area.

C. What is a safety margin?

A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. As noted in table 11, the emissions in the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL area are projected to have safety margins of 76.79 tpd for NOX and 23.76 tpd for VOC in 2030 (the difference between the attainment year 2014 emissions, and the projected 2030 emissions for all sources in the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL area). Even if emissions reached the full level of the safety margin, the counties would still demonstrate maintenance since emission levels would equal less than those in the attainment year.

As shown in table 13 above, Missouri is allocating a portion of that safety margin to the mobile source sector. Specifically, in 2030, Missouri is allocating 3.58 tpd and 14.43 tpd of the VOC and the NOX safety margins, respectively. MDNR is not requesting allocation to the MVEBs of the entire available safety margins reflected in the demonstration of maintenance. Therefore, even though the state is requesting MVEBs that exceed the projected onroad mobile source emissions for 2030 contained in the maintenance demonstration, the increase in onroad mobile source emissions that can be considered for transportation conformity purposes is well within the safety margins of the ozone maintenance demonstration. Further, once allocated to mobile sources, these safety margins will not be available for use by other sources.

VI. Proposed Action

EPA is proposing to determine that the Missouri portion of the St. Louis nonattainment area is attaining the 2008 ozone standard based on quality-assured and certified monitoring data for 2013-2015 and that the Missouri portion of the St. Louis area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.

EPA is also proposing to approve the state's request to change the designation of the Missouri portion of the St. Louis area for the 2008 ozone standard from nonattainment to attainment. EPA is also proposing to approve, as a revision to the Missouri SIP, the state's maintenance plan for the area. The maintenance plan is designed to keep the Missouri portion of the St. Louis area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA finds adequate and is proposing to approve the newly-establisheed 2030 MVEBs for the Missouri portion of the St. Louis area.

VII. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Environmental Protection Agency (EPA or the Agency) is proposing to establish no new requirements under Clean Water Act (CWA), section 311. This section directs the President to issue regulations to prevent discharges of oil and hazardous substances from onshore and offshore facilities, and to contain such discharges. On July 21, 2015, EPA was sued for failing to comply with the alleged duty to issue regulations to prevent and contain CWA hazardous substance discharges. On February 16, 2016, the United States District Court for the Southern District of New York entered a Consent Decree between EPA and the litigants that required EPA to sign a notice of proposed rulemaking pertaining to the issuance of hazardous substance regulations, and take final action after notice and comment on said notice. Based on an analysis of the frequency and impacts of reported CWA HS discharges and the existing framework of EPA regulatory requirements, the Agency is not proposing additional regulatory requirements at this time. This proposed action is intended to comply with the Consent Decree and to provide an opportunity for public notice and comment on EPA's proposed approach to satisfy the CWA requirements.

DATES:

Comments must be received on or before August 24, 2018.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2018-0024, “Clean Water Act Hazardous Substances Discharge Prevention Action” at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from https://www.regulations.gov/. The EPA may publish any comments received on its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The list of potentially affected entities in Table 1 may not be exhaustive. The Agency's aim is to provide a guide for readers regarding those entities that potentially could be affected by this action. However, this action may affect other entities not listed in this table. If you have questions regarding the applicability of this action to a particular entity, consult the person(s) listed in the preceding section entitled FOR FURTHER INFORMATION CONTACT.

C. What is the purpose of this proposed action?

The purpose of this proposal is to provide opportunity for public notice and comment on EPA's proposed approach to satisfy the requirements of CWA section 311(j)(1)(C) pertaining to CWA hazardous substances (HS).

II. BackgroundA. Statutory Authority and Delegation of Authority

CWA section 311(j)(1)(C) directs the President to issue regulations establishing procedures, methods, and equipment; and other requirements for equipment to prevent discharges of oil and HS from vessels and from onshore facilities and offshore facilities, and to contain such discharges.1 The President has delegated the authority to regulate non-transportation-related onshore facilities and offshore facilities landward of the coastline, under section 311(j)(1)(C) of the CWA to EPA.2

1 33 U.S.C. 1321(j)(1)(C).

2 Under Executive Order 12777(b)(1), the Department of the Interior has redelegated the authority to regulate non-transportation-related offshore facilities landward of the coastline to EPA (see 40 CFR part 112, Appendix B). A Memorandum of Understanding (MOU) between the U.S. Department of Transportation (DOT) and EPA (36 FR 24080, November 24, 1971) established the definitions of transportation- and non-transportation-related facilities. An MOU among EPA, DOI, and DOT, effective February 3, 1994, has redelegated the responsibility to regulate certain offshore facilities from DOI to EPA.

B. Legislative Background

The term “hazardous substance” is defined in CWA section 311(a)(14). Section 311(b)(2)(A) authorizes regulations designating HS, which when discharged in any quantity into jurisdictional waters,3 present an imminent and substantial danger to public health or welfare, including, but not limited to, fish, shellfish, wildlife, shorelines, and beaches.

3 The CWA 311 jurisdiction applies to discharges or substantial threats of discharges into or upon the navigable waters of the United States, adjoining shorelines, or into or upon the waters of the contiguous zone; in connection with activities under the Outer Continental Shelf Lands Act (43 U.S.C. 1331 et seq.) or the Deepwater Port Act of 1974 (33 U.S.C. 1501 et seq.); or which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States [including resources under the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.)] (“jurisdictional waters”). See 33 U.S.C. 1321(b)(1) and 33 U.S.C. 1321(c).

Once a chemical was designated as a CWA HS, as described in Section II.C, the corresponding quantity was established by regulation under the authority of CWA section 311(b)(4).4 The CWA prohibits discharges of CWA HS in quantities that may be harmful in section 311(b)(3).

4 CWA section 311(b)(4) provides for the President to, by regulation, determine for the purposes of this section, those quantities of oil and any hazardous substances, the discharge of which may be harmful to the public health or welfare or the environment of the United States, including but not limited to fish, shellfish, wildlife, and public and private property, shorelines, and beaches.

C. Regulatory Background

In March 1978, EPA designated a list of CWA HS in 40 CFR part 116. EPA established reportable quantities for those substances in 40 CFR part 117 in August 1979 (see, for example, 43 FR 10474, March 13, 1978; 44 FR 50766, August 29, 1979). In September 1978, EPA proposed to establish requirements for Spill Prevention, Control, and Countermeasure (SPCC) Plans to prevent CWA HS discharges from facilities subject to permitting requirements under the National Pollution Discharge Elimination System (NPDES) program of the CWA (43 FR 39276, September 1, 1978). The Agency proposed to require owners and operators to develop CWA HS SPCC Plans that included, among other things, general requirements for appropriate containment, drainage control and/or diversionary structures; and specific requirements for the proper storage of liquids and raw materials, preventive maintenance and housekeeping, facility security, and training for employees and contractors. EPA did not finalize that proposed CWA HS SPCC rule. There is no information in the record to explain the reason the 1978 proposal was not finalized.

D. Litigation Background

On July 21, 2015, the Environmental Justice Health Alliance for Chemical Policy Reform, People Concerned About Chemical Safety, and the Natural Resources Defense Council filed a lawsuit 5 against EPA for failing to comply with the alleged duty to issue regulations to prevent and contain CWA HS spills from non-transportation-related onshore facilities, including aboveground storage tanks, under CWA section 311(j)(1)(C).

On February 16, 2016, the United States District Court for the Southern District of New York entered a Consent Decree between EPA and the litigants establishing a schedule under which EPA is to sign “a notice of proposed rulemaking pertaining to the issuance of the Hazardous Substance Regulations” and take final action after notice and comment on said notice.6

EPA held three public meetings in 2016 to gain early input from stakeholders that EPA should consider during the rulemaking development. A public meeting was held in Charleston, West Virginia, on November 2; and two virtual public meetings were held on November 29 and December 1. EPA received input from a variety of stakeholders, including nongovernmental organizations, local governments, private citizens, and representatives from industry and trade organizations. Topics addressed in these discussions included:

• Require secondary containment and inspections of primary and secondary containment to assure continued compliance.

• Require information about downstream public water intakes to allow prompt notification after a spill.

• Concerns about CBI should not prohibit notifying residents about the risks of the chemicals stored or released.

• EPA must enforce standards for them to be effective.

• A number of Federal and state regulations already require spill prevention measures and EPA should not establish redundant or conflicting requirements.

The public input received is available in the docket.7

7 A summary of the input is available on the EPA website at: https://www.epa.gov/rulemaking-preventing-hazardous-substance-spills/summary-public-input-clean-water-act-cwa-hazardous, as well as in the docket for this proposal: Docket ID #: EPA-HQ-OLEM-2018-0024.

F. Additional Information Collection

We intend to supplement the information that this action is based on with an additional information collection. This information collection would be a voluntary survey of U.S. states, tribes, and territories that would request information on the number and type of facilities with CWA HS onsite; historical discharges of CWA HS; the ecological and human health impacts of those discharges; and existing state, territory, and Tribal programs that address discharge prevention of CWA HS. EPA anticipates using the results of the survey to further inform this regulatory action.8

8 On September 21, 2017, EPA issued a notice in the Federal Register (82 FR 44178) that identified plans to submit an information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval, and provided a 60-day public comment period.

III. Proposed Action

EPA is proposing no new regulatory requirements under the authority of CWA section 311(j)(1)(C) at this time. This determination is based on an analysis of identified CWA HS discharges, and an evaluation of the existing framework of EPA regulatory requirements relevant to preventing and containing CWA HS discharges.

The Agency set forth to determine what regulatory requirements under CWA section 311(j)(1)(C) would be appropriate to prevent CWA HS discharges. To this end, EPA analyzed the frequency of and reported impacts of the identified CWA HS discharges.

Next, EPA identified an analytical framework of discharge prevention, containment, and mitigation provisions, or program elements, commonly found in discharge and accident prevention regulatory programs. EPA then conducted a review of existing EPA regulatory programs to determine which regulations, such as NPDES, Resource Conservation and Recovery Act (RCRA), Risk Management Program (RMP), and others include these program elements and also apply to CWA HS.

Based on the reported frequency and impacts of identified CWA HS discharges, and the Agency's evaluation of the existing framework of EPA regulatory requirements relevant to preventing CWA HS discharges, EPA has determined that the existing framework of regulatory requirements serves to prevent CWA HS discharges. Additionally, EPA identified relevant requirements in other Federal regulatory programs and determined that they further serve to prevent CWA HS discharges, providing additional support for this proposed action.

A. CWA HS Discharge History and Impacts Analysis1. Discharge History and Reported Impacts

EPA analyzed CWA HS discharges reported to the National Response Center (NRC) 9 over a 10-year period to estimate the frequency of CWA HS discharges and to understand the reported impacts of these discharges to communities that were potentially affected.10 40 CFR 117.21 requires immediate notification to the NRC once the person in charge of a vessel or an offshore or onshore facility has knowledge of a discharge of a designated CWA HS from the facility in quantities equal to or exceeding, in any 24-hour period, the reportable quantity.

9 The NRC is the designated federal point of contact for reporting all oil, chemical, radiological, biological, and etiological discharges and releases into the environment anywhere in the United States and its territories. The NRC maintains a national database of these reports.

10 EPA recognizes that historical CWA HS discharges do not predict future incidents. EPA reviewed the CWA HS discharge history to gain insight into the frequency and impact of past CWA HS discharges.

During 2007-2016, the NRC received reports of 285,867 releases of all kinds (including for example of oil, chemical, radiological, biological to a variety of media). EPA then further analyzed the data to identify discharges of CWA HS that impacted water from facilities in EPA's regulatory jurisdiction. Based on the NRC database review 11 and recognizing the data limitations discussed further in Section III.A.3, EPA identified 9,416 reports of CWA HS discharges out of the total received (3.3 percent) for this time period. Of these CWA HS discharge reports, the Agency further refined the analysis by identifying 3,140 reports that were reported to have reached water (see discussion below on NRC data limitations). Within that universe, 2,491 (less than one percent of the reports) were identified as CWA HS discharges reported to have originated from non-transportation-related sources.

11 This review is described in detail in the Regulatory Impact Analysis in the docket (Docket ID No. EPA-HQ-OLEM-2018-0024) for this proposed action.

EPA further analyzed the NRC data to examine how many of the CWA HS discharges to water from non-transportation-related facilities had reported impacts. This information was supplemented with reported impact data for identified CWA HS discharges from the National Toxic Substance Incidents Program (NTSIP).12 Impacts reported to NRC and NTSIP include evacuations, injuries, hospitalizations, fatalities, waterway closures, and water supply contamination. A total of 117 CWA HS discharge reports (4.7 percent) included one or more of these impacts out of the 2,491 identified CWA HS discharges to water, reported as originating from non-transportation-related sources over the 10-year period analyzed.

12 The Agency for Toxic Substances and Disease Registry's NTSIP collects and combines information from many resources to protect people from harm caused by spills and leaks of toxic substances. NTSIP gathers information about harmful spills into a central place. People can use NTSIP information to help prevent or reduce the harm caused by toxic substance incidents. NTSIP can also help experts when a release does occur. See https://www.atsdr.cdc.gov/ntsip/ for additional information.

EPA seeks comment on the approach used to analyze the frequency of CWA HS discharges and to quantify the impacts of CWA HS discharges. Specifically, EPA requests additional data sources, information, and approaches that may allow EPA to further revise or refine the estimated impacts of CWA HS discharges from non-transportation-related sources, nationally.

2. Most-Frequently Discharged CWA HS

In addition to determining the frequency of CWA HS discharges, EPA also analyzed the reporting data to identify the CWA HS most frequently discharged. Of 292 CWA HS currently designated in 40 CFR part 116, the following 13 CWA HS comprised the majority of identified discharges, as well as the majority of identified discharges with reported impacts (Table 2).

These 13 CWA HS make up 90 percent of all identified CWA HS discharges to water from non-transportation-related facilities and 80 percent of the 117 identified CWA HS discharges with reported impacts.

3. NRC Data Limitationsa. Discharge History Limitations

The Agency looked to the NRC database as the best readily available source of information on CWA HS discharges in the United States. However, EPA recognizes its limitations. The NRC database is based on notifications of CWA HS discharges, and thus is dependent on the reporting individuals for comprehensiveness and accuracy of the information provided.

NRC reports are generally received immediately following an incident, often before a facility has accurate and complete information about the discharge. There is no requirement to update the information reported to the NRC; sometimes, the information available in the database includes inaccuracies regarding, among others, the substance reported, the quantity reported, the source, and the nature or impacts of the discharge. Further, some discharges may not be reported to the NRC, or the NRC may be notified of discharges that do not equal or exceed the reportable quantity. EPA has no information to assess or characterize the uncertainty associated with information reported to the NRC, the extent of under-reporting (failure to report a discharge), or the extent of over-reporting (discharges reported that are not subject to notification requirements).

Furthermore, the analysis conducted focused on those discharges that impacted water, but no additional determination was conducted to determine if the waters impacted were jurisdictional.13

13 Jurisdictional waters include navigable waters of the United States or adjoining shorelines, or the waters of the contiguous zone or in connection with activities under the Outer Continental Shelf Lands Act (43 U.S.C. 1331 et seq.) or the Deepwater Port Act of 1974 (33 U.S.C. 1501 et seq.), or which may affect natural resources belonging to, appertaining to, or under the exclusive management authority of the United States (including resources under the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.).

b. Discharge Impact Limitations

There may be additional impacts (i.e., beyond evacuations, injuries, hospitalizations, fatalities, waterway closures, and water supply contamination) from the universe of CWA HS discharges to water from non-transportation-related facilities, which were not required to be reported to the NRC and, thus, could not be quantified in this analysis. These may include the loss of productivity due to a facility or process unit shutting down as a result of a discharge, emergency response and restoration costs, transaction costs such as the cost of resulting litigation, damages to water quality, fish kills, or impacts to property values due to changes in perceived risk or reduced ecological services. EPA was not able to identify sources of data to quantify these impacts, other than the cited data from NRC or NTSIP and some limited information about fish kills that is made publicly available by a few states. The NRC and NTSIP data are discussed and analyzed in the RIA. The information EPA identified on fish kills is included in the docket.

c. Additional Efforts To Gather Data

EPA's initial data gathering efforts for this proposed action focused on assessing the scope of historical CWA HS discharges and identifying relevant industry practices and regulatory requirements related to preventing CWA HS discharges. EPA began to develop an information collection request (ICR) with a voluntary survey intended for facilities with CWA HS. EPA intended to collect information on current prevention practices and other facility-specific information that would inform the selection of prevention program elements for a proposed rule (e.g., storage capacity, types of storage equipment). However, EPA revised the focus of the survey after recognizing uncertainties in the estimate of the universe of potentially-subject facilities and the impacts associated with the 10-year CWA HS discharge data.

EPA intends to collect information from states to refine:

• The estimate of the universe of potentially-regulated facilities, and

• The analysis of CWA HS discharges in the 10-year period analyzed.

EPA provided notice on September 21, 2017 (82 FR 44179) of plans to submit an ICR to the OMB for review and approval of a voluntary survey intended for U.S. states, tribes, and territories. On April 10, 2018 (83 FR 15387) EPA provided notice that the ICR has been submitted to OMB for review and provided an additional 30-day public comment period.

EPA anticipates using any relevant information obtained through survey responses to further inform development of a regulatory action. If new information is received that informs the rulemaking, EPA will publish a notice to allow an opportunity for public review and comment of the information, as appropriate.

B. Analysis of Existing Regulatory Programs1. Program Elements

The Agency assessed current discharge prevention practices and technologies based on a review of existing EPA and other Federal regulatory programs.14 To further inform this analysis, EPA also reviewed state regulatory programs and industry standards, which are sometimes incorporated into state or Federal regulations as requirements. The purpose of this regulatory review was to identify common discharge and accident prevention, control and mitigation provisions that would serve to prevent, contain, or mitigate CWA HS discharges. EPA also analyzed past CWA HS discharges to determine what program elements could prevent or minimize impacts from these types of discharges in the future. Finally, EPA considered stakeholder input from the 2016 public meetings when identifying program elements (e.g., secondary containment and inspections, and downstream water notifications). See section II.E for a description of the early stakeholder input opportunities for this action.

14 Indiana's Department of Environmental Management took a similar approach when developing a report of aboveground storage tank rules and regulations. See IDEM's Report of Aboveground Storage Tank Rules and Regulations Pursuant to SEA 312; November 2015. https://www.in.gov/idem/cleanwater/files/ast_rules_overview.pdf.

EPA identified a framework of discharge prevention, containment, and mitigation provisions, or program elements, commonly found in discharge and accident prevention regulatory programs. These program elements are listed in Table 3 and discussed below and in the Background Information Document (BID).15

15 The analysis did not include administrative provisions, such as recordkeeping, which would normally be included in a regulatory program.

Table 3—Program Elements and Associated ProvisionsProgram elementsSample owner/operators requirementsPrevention Provisions:Safety InformationMaintain and review Safety Data Sheets (SDS).Hazard ReviewReview materials and operations at a facility, identify potential CWA HS discharge scenarios, and address them. Examples of resulting hazard mitigation measures could include storage container compatibility, engineering controls (e.g., uninterrupted power source) to address expected weather events, overfill prevention, explosion-proof requirements, and facility security measures.Mechanical IntegrityConduct preventive maintenance inspections, including process equipment and process control equipment, and implement appropriate corrective actions within specified timeframes.Personnel TrainingConduct initial and periodic personnel training for employees and contractors on proper facility operations, including any discharge prevention, mitigation, and response practices.Incident InvestigationsInvestigate CWA HS discharge causes, identify ways to prevent recurrence, document findings, and implement appropriate corrective actions.Compliance AuditsReview and document compliance with regulatory requirements. This could be an in-house or third-party review.Containment Provisions:Secondary ContainmentInstall and maintain secondary containment or diversionary structures to prevent a CWA HS discharge from reaching a waterway. Requirements could include specifications for size requirements, freeboard for precipitation, and imperviousness.Mitigation Provisions:Emergency Response PlanDevelop an emergency response plan that includes information and procedures needed in the event of a discharge to mitigate the impacts of the discharge, ensure the safety of responders and facility personnel, and to notify potential receptors.Coordination with State and Local RespondersCoordinate with state and local responders on response and notification procedures prior to a CWA HS discharge.

A summary of the program elements is included below.

a. Safety Information

As part of prevention planning, owners/operators should maintain and review safety information about the chemicals they handle and the equipment involved in their operations. Knowledge and understanding of this information could serve to maintain overall safe operations, reducing the potential for CWA HS discharges. Chemical safety information, for example, would be useful when conducting a hazards review, developing a mechanical integrity program, or developing training materials for equipment operators.

Examples of safety information include SDS, as well as manufacturers' specifications for operating equipment. A safety information program element ensures that facility personnel have information to help them understand the safety-related aspects of their materials, equipment, and processes; and recognize the limits that are placed on their operations.

b. Hazard Review

The hazard review process is intended to identify potential chemical or operational hazards present in a process. The task of identifying potential hazards could inform changes in operations that would prevent CWA HS discharges. A hazard review could provide information key to the proper design, construction, and operation of facility equipment/systems (e.g., identifying a risk of corrosion that can be mitigated by ensuring compatibility of the container with the stored material) or choosing engineering controls (e.g., identifying a risk of overfilling may lead to installing alarms or an automatic shutoff mechanism, installing an uninterrupted power supply in case of loss of power). Hazard review program provisions could be designed to focus facilities on identifying process hazards that may cause a discharge in order to control or prevent these discharges.

c. Mechanical Integrity Program

Process equipment widely varies and may include, for example, containers, piping, valves, pumps, loading racks, reactors, control systems, vents or relief devices, wastewater treatment systems, or other equipment that could be potential sources of CWA HS discharges. Facilities develop and implement mechanical integrity programs to ensure proper equipment operation and maintenance, which not only serve to prevent CWA HS discharges, but can also ensure operational reliability and safe operation at a facility.

Training programs for employees and/or contractors help ensure they are aware of proper and/or safe operating procedures, chemical hazards, discharge prevention and containment measures, and response procedures. A training program aims to reduce operator errors that could lead to CWA HS discharges and educate operators on the proper implementation of discharge prevention measures.

Personnel training can also strengthen the implementation of other program elements, such as hazard review or mechanical integrity, by helping employees understand operational procedures established by those program elements. Training programs may include specific prevention and response procedures, which have been developed to prevent, contain, and mitigate CWA HS discharges; or include more general provisions for the safe and proper operation of equipment to prevent accidents due to operator error.

e. Incident Investigations

Incident investigations examine the causes of a discharge after it has occurred. Lessons learned from incident investigations can then be applied to inform future prevention activities, and may result in improvements to operational methods, process design, or preventative maintenance procedures with the goal of preventing future CWA HS discharges. Incident investigation requirements may include conducting the investigation, documenting the findings, developing procedures to address the findings, and sharing the results with relevant employees.

Incident investigation provisions applicable to CWA HS discharges may serve to document findings of a discharge and implement appropriate corrective actions aimed at preventing future discharges. For example, depending on the identified cause of a CWA HS discharge, one-time corrective actions could be implemented (e.g., installing an engineering control), or a programmatic or management approach could be implemented through another program element (e.g., changes to a preventive maintenance inspection schedule under the mechanical integrity program, or changes to employee training materials).

f. Compliance Audits

Compliance audits serve as a mechanism to evaluate and measure a facility's compliance with regulatory requirements. An audit reviews a facility's operations and practices to determine whether or not applicable regulatory requirements are being met. Compliance audits identify deficiencies and opportunities for improvement, and may be accomplished by in-house personnel or by an outside third party. A compliance audit could be accomplished by a Professional Engineer or other person with liability/professional standards and knowledge of the specific processes and applicable regulations.

A compliance audit provision could provide facility management with a mechanism for oversight of implementation of CWA HS discharge prevention practices, and could include reports documenting the audit and follow-up actions.

g. Secondary Containment

When properly designed and maintained, secondary containment systems can prevent discharges to jurisdictional waters. Secondary containment provisions could include dikes, berms, diversionary structures, sumps, spill kits, or other means of preventing discharges of CWA HS into jurisdictional waters. Secondary containment systems provide a second line of defense in the event of a failure of the primary containment, such as bulk storage containers, plant equipment, portable containers, or piping. Secondary containment design considerations may include passive or active measures, appropriate volumes, impermeability of containment structures, and freeboard for precipitation.

Secondary containment provisions for CWA HS equipment could require, for example, specific sizing requirements for a worst-case discharge (e.g., construction of secondary containment sized to contain a CWA HS discharge from the largest container) or a typical discharge incident (based on a most-likely scenario); design specifications to address impervious construction; maintenance provisions, including inspections to ensure the designed capacity is maintained (e.g., by removing rainwater or other debris); and corrective actions to ensure that inspection results are addressed.

h. Emergency Response Plan

Emergency response plans describe immediate response actions to be taken after a CWA HS discharge in order to mitigate the impacts of the discharge, and may include key information that could be quickly accessed when needed. These plans identify not only the steps to be taken by facility personnel to mitigate the severity and environmental impacts of a discharge, to make appropriate notifications to local, state and Federal authorities, and also typically includes safety information to protect employees and emergency responders. Including an emergency response plan as part of a prevention program is complementary, since it requires facility owners/operators to proactively (i.e., in advance of the discharge) gather information and develop immediate actions to be initiated quickly following a CWA HS discharge. Additional considerations for emergency response plans may include procedures for notifying potential receptors of the CWA HS discharge or requirements to have ready access to information about proper medical treatment for ingestion of CWA HS that impact drinking water supplies.

i. Coordinating Emergency Response Plan With State and/or Local Responders

Coordination between facility personnel and state and/or local responders on the content of the facility's emergency response plan allows for an information exchange that can improve emergency responders' understanding of the potential hazards onsite and ensure an effective response following a discharge.

For example, Local Emergency Planning Committees (LEPCs) include representatives from the local community (including elected state and local officials; police, fire, civil defense, and public health professionals; facility representatives; and community group representatives). LEPCs develop an emergency response plan for the community, and provide information about chemicals in the community to citizens. Where there is no active LEPC, different entities such as fire departments, emergency management agencies, police departments, or public health agencies may be planning and/or assisting in an incident response.

Coordination with state and local responders prior to a CWA HS discharge could help mitigate the impacts of a CWA HS discharge (e.g., allow for a timely shutdown of downstream drinking water intakes). Provisions could require facility personnel to share their emergency response plans with the appropriate local or state entities that would respond in the event of a CWA HS discharge. This could include an LEPC, as well as other local authorities in charge of coordinating source water protection for public drinking water systems or for other receptors.

2. Existing Regulatory Requirements

EPA analyzed the Federal programs and corresponding regulations identified in Table 4, focusing on these program elements, to better understand the existing regulatory requirements, practices, and technologies currently used at facilities to prevent CWA HS discharges. These regulatory programs were selected because they include discharge or accident prevention requirements and were identified as regulating at least some CWA HS; or regulating at least some facilities that produce, store, or use CWA HS. For example, the SPCC rule in 40 CFR part 112 was reviewed because more than 50 percent of the 2,491 identified CWA HS discharges in the NRC data were discharges of PCBs, reported as present in transformer oil. Storage and handling of transformer oil is subject to the SPCC rule when a facility meets the applicability criteria of 40 CFR part 112.

The CWA NPDES Permit Program, authorized by the CWA, controls water pollution by regulating point sources that discharge pollutants into waters of the United States. An NPDES permit establishes limits on what can be discharged, monitoring and reporting requirements, and other provisions to protect water quality. In essence, the permit translates general requirements of the CWA into specific provisions tailored to the operations of the facility discharging pollutants. Regulations at 40 CFR 122.26(b)(14)(i)-(xi) require stormwater discharges associated with specific categories of industrial activity to be covered by NPDES permits, unless otherwise excluded. An NPDES general permit may be written to establish requirements that apply to eligible facilities with similar operations and types of discharges that obtain authorization to discharge under the general permit. Many states are currently authorized to issue NPDES permits for industrial stormwater.

This review focused on the provisions in one industrial stormwater general permit, the Multi-Sector General Permit for Stormwater Discharges Associated with Industrial Activity, issued by EPA in 2015.16 The MSGP is a general permit that is available to facilities that do not discharge to a state with NPDES permitting authority. Because many states model their industrial stormwater permits after EPA's permit, it was used to identify prevention requirements likely to be present in NPDES industrial stormwater permits issued by states.

16 EPA focused on stormwater permits for this review because the requirements apply where stormwater from an industrial property has the potential to discharge to a waterway. The MSGP's requirements apply to all pollutants present in the regulated stormwater discharge, including all toxic pollutants, conventional pollutants, and non-conventional pollutants. As such, the MSGP controls what this notice refers to as CWA HS. Further, the MSGP permit is representative of stormwater permits in general.

NPDES stormwater permits for industrial activity contain effluent limits that correspond to required levels of technology-based and water quality-based controls for discharges (CWA 402(p)(3)(A)). In the MSGP, most of the effluent limits are expressed as non-numeric pollution prevention or best management practice (BMP) requirements for minimizing the pollutant levels in the discharge (40 CFR 122.44(k)). To identify existing requirements relevant to preventing CWA HS discharges, EPA focused on non-numeric effluent limitations in Section 2 of the permit, including good housekeeping and maintenance requirements, and Stormwater Pollution Prevention Plan requirements in Section 5 of the MSGP.

The 2015 MSGP for Industrial Stormwater includes discharge prevention and response measures to minimize stormwater contamination (see part 2.1.2.4 of the MSGP). These requirements include plainly labeling containers susceptible to spillage or leakage to encourage proper handling and facilitate rapid response if spills or leaks occur; and implementing procedures for material storage and handling, including the use of secondary containment and barriers between material storage and traffic areas, or a similarly effective means designed to prevent the discharge of pollutants from these areas.

Applicability criteria. The industrial sectors and activities covered by the MSGP are listed in Appendix D of the permit, while another version of that list of industries is included in Appendix N. The permit is meant to control and minimize pollutants in stormwater discharges associated with specific categories of industrial activities. This permit is available only to facilities that meet the eligibility criteria described in the MSGP where EPA is the permitting authority. Regulated facilities under the jurisdiction of authorized states are expected to be subject to similar provisions in a state-issued NPDES permit.

Equipment or operations at which requirements apply. The permit's requirements apply to discharges of stormwater from activities and areas at a regulated industrial plant, including industrial processes and activities such as material handling, material storage, and equipment maintenance and cleaning.

b. RMP Rule (40 CFR Part 68)

The Chemical Accident Prevention Provisions, also known as the RMP Rule, require facilities that use certain listed, regulated substances to develop and implement a RMP. The RMP Rule is authorized by the Clean Air Act (CAA). Regulated facilities are also required to develop an RMP, which must identify the potential effects of a chemical accident, identify steps the facility is taking to prevent an accident, and spell out emergency response procedures should an accident occur. Regulated facilities must submit a single RMP for all covered processes at the facility; these plans must be revised and resubmitted every five years.

Applicability criteria. The RMP requirements apply to facilities (stationary sources) that manufacture, use, store, or otherwise handle more than a threshold quantity of a regulated substance in a process. The RMP Rule provides a List of Regulated Substances under section 112(r) of the CAA. The 140 RMP-regulated substances, and their threshold quantities, are listed at 40 CFR 68.130. The list includes 77 acutely toxic chemicals that can cause serious health effects or death from short-term exposures, as well as 63 flammable gases and highly volatile flammable liquids that have the potential to form vapor clouds and explode or burn if released. RMP-regulated substances include some CWA HS. The rule defines three program levels based on the processes' relative potential for public impacts and the level of effort needed to prevent accidents. For each program level, the rule defines requirements that reflect the level of risk and effort associated with the processes at that level. As a result, different facilities covered by the regulation may have different requirements depending on their processes.

Equipment or operations at which requirements apply. The RMP requirements apply to facilities that have more than a threshold quantity of a regulated substance in a process. Therefore, the requirements in the rule apply to processes. A process means any activity involving a regulated substance including any use, storage, manufacturing, handling, or onsite movement of such substances, or combination of these activities. For example, 40 CFR 68.25 requires that, for each process at the stationary source, the facility owner/operator analyze and report worst-case release scenarios.

c. SPCC Rule (40 CFR Part 112)

The portion of the Oil Pollution Prevention regulation known as the SPCC Rule, authorized by the CWA, is designed to protect public health, public welfare, and the environment from potential harmful effects of oil discharges to navigable waters or adjoining shorelines. The SPCC Rule requires certain facilities that could reasonably be expected to discharge oil in quantities that may be harmful into jurisdictional waters or adjoining shorelines to develop and implement SPCC Plans. Subparts A through C of 40 CFR part 112 are often referred to as the SPCC Rule. The SPCC Plan includes several elements to prevent oil spills, including a facility diagram, oil discharge predictions, secondary containment or diversionary structures, overfill prevention, requirements for inspections, transfer procedures, personnel training, and a five-year plan review.

Applicability criteria. The SPCC Rule applies to any owner or operator of a non-transportation-related onshore or offshore facility engaged in drilling, producing, gathering, storing, processing, refining, transferring, distributing, using, or consuming oil and oil products, which, due to its location, could reasonably be expected to discharge oil in quantities that may be harmful. The rule applies to facilities with an aboveground storage capacity of more than 1,320 gallons of oil (except farms 17), or a completely buried storage capacity of more than 42,000 gallons of oil. The rule has a number of exemptions, such as an exemption for containers used for wastewater treatment.

17 Farms are exempt under two circumstances: (1) If the farm has less than 6,000 gallons of aboveground storage and no reportable oil discharge history; or (2) has 2,500 gallons or less of aboveground storage, regardless of reportable oil discharge history.

While the SPCC Rule applies only to oil, it regulates oil mixed with other substances, including a CWA HS. The definition of oil can be found in 40 CFR 112.2: “Oil means oil of any kind or in any form, including, but not limited to: Fats, oils, or greases of animal, fish, or marine mammal origin; vegetable oils, including oils from seeds, nuts, fruits, or kernels; and, other oils and greases, including petroleum, fuel oil, sludge, synthetic oils, mineral oils, oil refuse, or oil mixed with wastes other than dredged spoil.”

Equipment or operations at which requirements apply. Some SPCC requirements apply facility-wide and some apply to specific equipment. For example, 40 CFR 112.7(f) requires that all oil-handling personnel must be trained in the operation and maintenance of equipment to prevent discharges; discharge procedure protocols; applicable pollution control laws, rules, and regulations; general facility operations; and the contents of the facility SPCC Plan. Alternatively, the integrity testing and inspection provisions found at 40 CFR 112.8(c)(6) apply to bulk storage containers.

The Pesticide Management and Disposal regulation establishes standards for pesticide containers and repackaging as well as label instructions to ensure the safe use, reuse, disposal, and adequate cleaning of the containers. Pesticide registrants and refillers (who are often distributors or retailers) must comply with the regulations, and pesticide users must follow the label instructions for cleaning and handling empty containers. Specifically, the Pesticide Management Regulation at part 165 establishes standards and requirements for pesticide containers, repackaging pesticides, and pesticide containment structures (§ 165.1). Twenty-one states implement pesticide containment regulations in lieu of federal containment regulations in 40 CFR part 165.

Applicability criteria. The requirements apply to chemicals that meet the definition of pesticide. One hundred and nine designated CWA HS may be used as pesticides subject to the 40 CFR part 165 FIFRA requirements.

Equipment or operations at which requirements apply. Most requirements in 40 CFR part 165 apply to containers and pesticide manufacturers are responsible for meeting these requirements. For example, 40 CFR 165.25(a) and 165.45(a) require pesticide containers to meet certain DOT packaging requirements even if the pesticide is not a DOT hazardous material. Similarly, § 165.65(e) requires visual inspection of a refillable container before repackaging a pesticide product into it, to determine whether the container meets the necessary criteria with respect to continued container integrity, required markings, and openings.

The regulation also includes requirements that apply to the area where stationary containers are stored and/or pesticide dispensing areas. For example, 40 CFR 165.85 provides design and capacity requirements for secondary containment structures at these areas. The requirements at § 165.90(a)(1) further state that containment structures must be managed in a manner that prevents pesticides or materials containing pesticides from escaping from the containment structure.

FIFRA regulates worker safety through Workplace Protection Standards in 40 CFR part 170. Farms, forests, nurseries, and greenhouses that handle pesticides used to produce agricultural plant crops must adopt workplace practices designed to reduce or eliminate exposure to pesticides, and must follow procedures for responding to exposure-related emergencies.

Applicability criteria. The requirements apply to chemicals that meet the definition of pesticide. One hundred and nine designated CWA HS may be used as pesticides subject to the 40 CFR part 165 FIFRA requirements.

Equipment or operations at which requirements apply. The Worker Protection Standard requirements in 40 CFR part 170 apply to employers of pesticide workers and handlers. For example, 40 CFR 170.501 requires employers to provide training to all pesticide handlers (who mix, load, and apply agricultural pesticides) every 12 months.

This RCRA Rule establishes cradle-to-grave hazardous waste management standards for generators of hazardous waste as defined by § 260.10. These generator regulations ensure that hazardous waste is appropriately identified and handled in a manner that protects human health and the environment, while minimizing interference with daily business operations.

The rule sets forth a process for generators of solid waste to determine if their wastes are hazardous, and for generator category determination (based on the amount of hazardous waste generated each month). It provides manifest requirements, pre-transport (e.g., packaging, labeling) requirements, and recordkeeping and reporting requirements for both small and large quantity generators. Some generators are also subject to preparedness, prevention, and emergency response requirements.

Applicability criteria. The RCRA Generators Regulation applies to generators of hazardous waste. Hazardous wastes, defined in § 261.3, may include specifically “listed” hazardous wastes, or “characteristic” hazardous wastes evaluated based on four criteria (ignitability, corrosivity, reactivity, and toxicity). Some listed hazardous wastes are CWA HS (e.g., toluene), and some CWA HS would meet criteria for characteristic hazardous wastes at certain concentrations if the CWA HS were present as waste. RCRA regulations apply only to waste materials (as opposed to raw materials or intermediate products). This rule establishes different requirements for very small, small, and large quantity generators of hazardous waste.

Equipment or operations at which requirements apply. Some provisions apply to facility areas. For example, 40 CFR 262.252 requires that all subject areas must be equipped with an internal communications or alarm system, a device to summon emergency assistance, portable fire extinguishers and other fire/spill control equipment, and adequate volumes of water or foam-producing equipment. Other provisions apply to packages. For example, § 262.31 requires that the generator must label each package of hazardous waste in accordance with the applicable DOT regulations on hazardous materials (49 CFR part 172).

The purpose of the RCRA Treatment, Storage, and Disposal Facilities (TSDF) Standards is to establish minimum national standards for the acceptable management of hazardous waste.

Part 264 applies to permitted TSDFs, while part 265 applies to interim status facilities. Both parts 264 and 265 provide general facility and unit-specific operating requirements to assure that a facility is operated in a manner that is protective of human health and the environment.

Applicability criteria. The standards apply to owners and operators of facilities that treat, store, or dispose of hazardous waste. Hazardous waste is defined in § 261.3. Hazardous wastes may include specifically “listed” hazardous wastes; or “characteristic” hazardous wastes, which are identified as hazardous based on four criteria (ignitability, corrosivity, reactivity, and toxicity.) Some listed hazardous wastes are CWA HS (e.g., toluene); and some CWA HS would meet criteria for characteristic hazardous wastes at certain concentrations, if the CWA HS were being discarded and thus a waste. A facility includes all contiguous land, structures, and appurtenances on or in the land used for treating, storing, or disposing of hazardous waste.

Equipment or operations at which requirements apply. The standards in 40 CFR parts 264 and 265 include facility-wide requirements, such as good housekeeping provisions, as well as unit-specific design and operating criteria. A single facility may consist of several types of operational units (e.g., containers, tank systems, surface impoundments, waste piles, landfills, incinerators). The unit-specific technical requirements are designed to prevent the release of hazardous waste into the environment. For example, § 264.184 includes container-specific requirements governing design and operating requirements for storage area containment systems.

UST regulations, authorized by RCRA, are intended to reduce the chance of releases from USTs, detect leaks and spills when they do occur, and secure a prompt cleanup. The regulations require owners and operators to properly install UST systems and protect their USTs from spills, overfills, and corrosion; they also require correct filling practices to be followed. In addition, owners and operators must report new UST systems, suspected releases, and UST system closures; and they must keep records of operation and maintenance.

Equipment or operations at which requirements apply. Some requirements apply to equipment. For example, the compatibility requirements at 40 CFR 280.32 state that UST systems must be made of or lined with materials that are compatible with the substance stored in the UST system. Other requirements apply to areas or processes. For example, areas directly surrounding the tanks are protected by requirements such as the spill and overfill control measures in § 280.30, which calls for the constant monitoring of transfer operations.

The EPCRA planning rule requires regulated facilities to provide information necessary for developing and implementing state and local emergency response plans. It also requires emergency notification in the event of a release of a regulated chemical. The facility owner/operator must designate a facility representative who will participate in the local emergency planning process as a facility emergency response coordinator, and provide notice to the LEPC (§ 355.20(b)).

Applicability criteria. The emergency planning requirements in 40 CFR part 355 apply to facilities with an extremely EHS onsite in amounts equal to or greater than its designated threshold planning quantity (TPQ). EHS is defined in Appendices A and B of 40 CFR part 355. EHS include 65 substances, all of which are also designated as CWA HS.

The emergency release notification requirements in 40 CFR part 355 apply to facilities that produce, use, or store a hazardous chemical, and that also release a reportable quantity of either an EHS or a CERCLA hazardous substance as defined by CERCLA. All CWA HS are defined as CERCLA hazardous substances.

Equipment or operations at which requirements apply. These requirements apply to an entire facility.

The EPCRA reporting rule establishes reporting requirements for facilities to provide state and local officials with information on hazardous chemicals present at the facility. The information submitted by the facilities must also be made available to the public.

Applicability criteria. This rule applies to facilities that are required by the OSHA HazCom regulation to have an SDS available, and handle or store hazardous chemicals in quantities that equal or exceed the following thresholds:

• For EHS, either 500 pounds or the TPQ, whichever is lower. EHS is defined in Appendices A and B of 40 CFR part 355.

• For all other hazardous chemicals, 10,000 pounds. A hazardous chemical is defined by OSHA HazCom at 29 CFR 1910.1200(c) and § 1910.1200(c) defines chemical. This definition includes all CWA HS.

Equipment or operations at which requirements apply. The hazardous chemical reporting requirements in 40 CFR part 370 apply to individual chemicals rather than process equipment. For example, regulated facilities must submit an SDS for the subject chemicals to the LEPC, the State Emergency Response Commission (SERC), and the local fire department as described in §§ 370.30 to 370.33.

The requirements at 40 CFR part 430 were promulgated as part of the “Cluster Rule” for the Pulp, Paper, and Paperboard Industry; are authorized by the CWA and CAA; and establish requirements under multiple statutes for multiple environmental media. The Cluster Rule was included in EPA's review of existing requirements because it includes BMPs for spent pulping liquor, soap, and turpentine in § 430.03, which includes spill prevention and control measures and the requirement to develop a BMP Plan.

Applicability criteria. These requirements apply to any pulp, paper, or paperboard mill that discharges or may discharge process wastewater pollutants to the waters of the United States; or that introduces or may introduce process wastewater pollutants into a publicly owned treatment works.

The relevant BMPs apply specifically to direct and indirect discharging pulp, paper, and paperboard mills with pulp production in Subparts B and E of part 430 in order to prevent spills and leaks of spent pulping liquor, soap, and turpentine. Subparts B (Bleached Papergrade Kraft and Soda) and E (Papergrade Sulfite) define effluent limitations for a limited number of CWA HS.

Equipment or operations at which requirements apply. The requirements apply to pieces of equipment and process areas. For example, 40 CFR 430.03(c)(2)(i) requires regular visual inspections of process areas with equipment items in spent pulping liquor service. As another example, under 40 CFR 430.03(c)(4), the mill must establish a program of initial and refresher training of operators, maintenance personnel, and other technical and supervisory personnel who have responsibility for operating, maintaining, or supervising the operation and maintenance of equipment items in spent pulping liquor, soap, and turpentine service.

l. Other Federal Programs

Although the analysis of existing EPA regulations is the basis for this proposal, EPA reviewed other Federal regulations with prevention requirements that may be applicable to CWA HS. For more information about these requirements, see Background Information Document: Review of Relevant Federal and State Regulations; Docket ID #: EPA-HQ-OLEM-2018-0024.

EPA also identified state regulatory programs,18 which regulate the proper handling and storage of chemicals to prevent accidents and discharges, and industry standards that establish technology standards and recommend practices prudent for proper operation and maintenance. A review of these state programs and industry standards is presented in the BID.

EPA cross-referenced the regulatory requirements for the Federal programs in Table 4—Reviewed Federal Programs and Corresponding Regulations with the nine program elements in Table 3—Program Elements and Associated Provisions to identify existing regulatory programs that include discharge prevention, control, and mitigation provisions. The relevance of each EPA/Federal program and corresponding regulations to the cross-referenced program elements and their associated provisions is summarized in Table 5—Review of EPA and Other Federal Regulations for Program Elements, and is discussed in detail in the BID available in the docket for this proposal.19 For each regulatory program, this high-level analysis documents provisions related to each of the nine program elements identified.

The analysis indicates that, for all nine program elements, there are existing cumulative EPA regulatory requirements under various programs for accident and discharge prevention relevant to CWA HS. Similarly, existing cumulative requirements under Federal regulatory programs administered by other Federal agencies and departments (i.e., OSHA, MSHA, PHMSA, and OSMRE) reflect, under various accident and discharge prevention programs, all nine program elements. This information is summarized in detail in the BID. For example, Table 5—Review of EPA and Other Federal Regulations for Program Elements shows that hazard review and emergency response planning provisions are the two most frequently addressed program elements; these were identified in seven of eight EPA regulations and in all of the other Federal programs reviewed.

BILLING CODE 6560-50-PEP25JN18.009BILLING CODE 6560-50-C

The analysis focused on those provisions within the existing EPA, and other Federal, regulatory framework that address to varying degrees, either directly or indirectly, the identified program elements for CWA HS. The compliance auditing program element is addressed by one EPA regulatory program (RMP) and one other Federal regulation (the OSHA Process Safety Management standard). Mechanical integrity and personnel training are addressed by seven of eight EPA programs and by three of the other Federal programs reviewed. Secondary containment provisions are included in six of eight EPA regulations and three additional Federal programs reviewed. The remaining program elements (i.e., safety information; incident investigations; and coordination with state and local responders) are addressed by approximately half of the Federal regulations reviewed.

The BID provides details on how each program element is addressed by both EPA regulations and other Federal programs. A summary of the EPA regulations, that serve as the basis for this proposal, is provided below.

a. Safety Information

Of the 11 EPA regulations reviewed, three programs include requirements to identify safety information for chemicals used or stored on-site—the Pesticide Worker Protection Standard, the RMP Rule and the EPCRA Reporting Rule.

The Pesticide Worker Protection Standard requires agricultural establishments to display safety data sheets for the pesticides that have been applied on the establishment and to keep the SDSs in records for two years.

The RMP Rule requires owners or operators to compile and maintain general safety information, including: An SDS, maximum intended inventory of equipment in which the regulated substances are stored or processed, and safe operation conditions. The RMP rule also requires owners to compile process safety information for regulated substances, such as toxicity information.

The EPCRA Reporting Rule, which establishes Tier I and Tier II reporting requirements, requires regulated facilities to submit identifying information, either as an SDS or a list of hazardous substances grouped by specific hazards, for hazardous substances. In addition, an inventory of the chemicals for the preceding calendar year must be submitted to the facility's State Emergency Response Commission (SERC), LEPC, and local fire department.

b. Hazard Review

Eight EPA regulations reviewed include requirements for facilities to conduct a hazard review or identify hazards:

• MSGP for Industrial Stormwater;

• RMP Rule;

• SPCC Rule;

• Pesticide Management Regulation;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• UST Rule; and

• EPCRA Reporting Rule.

The program element or sub-elements most commonly required by EPA programs are identification of engineering or administrative controls and/or a requirement for equipment/containers to be constructed in accordance with standards (six regulatory programs), requirement for compatibility of stored materials with tanks and equipment (five regulatory programs), and overfill prevention (six programs).

A general hazard review and identification of process hazards is required by four EPA regulatory programs—the 2015 MSGP for Industrial Stormwater, RMP Rule, SPCC Rule and RCRA TSD Regulations. Four programs, the MSGP for Industrial Stormwater, SPCC Rule, RCRA TSD Regulations and EPCRA Reporting Rule, require description of process technology or equipment for risk identification. The 2015 MSGP for Industrial Stormwater requires permitted facilities to assess potential hazards, implement control measures to minimize discharge based on identified hazards, and compile a list of the industrial activities exposed to stormwater. The RMP Rule requires facilities, depending on applicability, to either develop a hazard review or a process hazard analysis. The SPCC Rule requires that regulated facilities develop spill prevention, control and countermeasure plans that include a review of equipment and processes with a reasonable potential for failure.

Compatibility of stored materials with tanks and equipment is required by five EPA regulatory programs—Pesticides Management Regulation, the SPCC Rule, RCRA Generators Regulation, RCRA TSD Regulations, and the UST Rule. Most of the regulatory programs have a general requirement that tanks or equipment (or tank lining) must be compatible with the stored material. The Pesticides Management Regulation requires compatibility of containers and pesticides stored by referring to and requiring compliance with the DOT Hazardous Materials Packaging Regulations, and also requires that each stationary pesticide container and its appurtenances are resistant to extreme changes in temperature and constructed of materials that are adequately thick to not fail and that are resistant to corrosion, puncture, or cracking. This requirement is included because material incompatibility can result in corrosion, which implicitly requires pesticide storage facilities to incorporate hazard review in order to satisfy the requirement.

Six EPA regulatory programs have a broad requirement to identify engineering or administrative controls or that equipment or containers are to be constructed in accordance with industry codes or standards. Four specific types of engineering or administrative controls were reviewed: General engineering or administrative controls (e.g. temperature control), alarms, inventory management, and overfill prevention. The most commonly required engineering or administrative control is general controls. For example, the RCRA TSD Regulations at 40 CFR part 264 requires that containers holding hazardous waste remain closed during storage, except when it is necessary to add or remove waste, which is a control to prevent discharges. The RCRA Generators Regulation requires large quantity generators to use inventory logs to monitor hazardous waste. The UST Rule requires that owners or operators monitor hazardous substance transfer between tanks to avoid overfilling or spills. These forms of engineering or administrative controls may prevent discharges.

c. Mechanical Integrity

Eight regulations include requirements for facilities to maintain mechanical integrity of equipment critical for safe operation:

• MSGP for Industrial Stormwater;

• RMP Rule;

• SPCC Rule;

• Pesticide Management Regulation;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• UST Rule; and

• Pulp and Paper Effluent Guidelines.

Five of the reviewed EPA regulations (MSGP for Industrial Stormwater, RMP Rule, SPCC Rule, RCRA TSD Regulations, and Pulp and Paper Effluent Guidelines,) have a general mechanical integrity program element requirement, eight require inspections and testing, and seven require corrective action as a result of these inspections and tests. For example, the 2015 MSGP for Industrial Stormwater addresses a mechanical integrity program element and requires maintenance of non-structural control measures (e.g., ensuring availability of spill response supplies, maintenance training). The SPCC Rule requires that facilities' SPCC Plans include inspections and mechanical integrity.

These regulations vary considerably in scope, such as inspection frequency. For example, the Pulp and Paper Effluent Guidelines require best management practices that involve daily inspection of equipment for leaks for the pulp and paper sector while the 2015 MSGP for Industrial Stormwater requirements emphasize preventative maintenance on equipment that could result in contamination of stormwater. The RMP Rule requires facilities to inspect equipment at a frequency recommended by the manufacturer or industry standards and also to keep records of inspections.

d. Personnel Training

Of the 11 EPA regulations reviewed, eight include training requirements for employees or contractors that could serve to prevent CWA HS discharges:

• MSGP for Industrial Stormwater;

• RMP Rule;

• SPCC Rule;

• Pesticide Worker Protection Standard;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• UST Rule; and

• Pulp and Paper Effluent Guidelines.

These regulations frequently outline prescribed content that must be covered in the employee and/or contractor training. These training programs typically require training related to safe operation of equipment as well as emergency response procedures when a spill occurs. For example, the RCRA TSD and Generators Regulations require that facility personnel are trained in hazardous waste management procedures, including equipment monitoring, automatic waste feed cut-off systems, alarm systems, response to fires or explosions, response to ground-water contamination incidents, and emergency shutdown of operations. Similarly, the Pesticide Worker Protection Standard requires training for pesticide handlers to include safety requirements for handling, transporting, storing, and disposing of pesticides, including general procedures for spill cleanup. The MSGP for Industrial Stormwater (2015) has a general requirement for permit holders to develop training on the procedures for expeditiously stopping, containing, and cleaning up leaks, spills, and other releases.

Seven of the eight EPA regulations reviewed specifically for personnel training also include a requirement specific to refresher training. Most programs require that employees receive a review or refresher training at least annually. For example, the RMP Rule requires that refresher training is completed every three years.

e. Incident Investigations

Three EPA regulations include an incident investigation program element:

• Pulp and Paper Effluent Guidelines;

• SPCC Rule; and

• the RMP Rule.

These three EPA regulations that include an incident investigation program element require facilities to determine the cause of an incident. The SPCC Rule requires that facilities undertake an incident investigation and submit a report within 60 days if they discharged 1,000 U.S. gallons of oil or more in a single discharge or more than 42 U.S. gallons of oil in each of two discharges. This incident investigation must include an analysis of the cause of the discharge, corrective action taken, and additional preventive measures that would minimize the possibility of recurrence. The RMP Rule requires that incident investigations are initiated within 48 hours of an accidental release and include factors that contributed to the incident as well as recommendations resulting from the investigation. Finally, the Pulp and Paper Effluent Guidelines require that mills conduct an incident investigation after a spill and generate a report that identifies changes in operations and equipment, as necessary to prevent recurrence.

f. Compliance Audits

Of the 11 EPA regulations reviewed, the RMP rule is the only one that requires compliance audits. The RMP Rule requires owners or operators of stationary sources with regulated chemicals to evaluate their compliance with the RMP Rule every three years. If they find areas of deficiency, they must determine and document an appropriate response and correct the deficiency.

g. Secondary Containment

Seven EPA regulations were found to contain secondary containment provisions:

• MSGP for Industrial Stormwater;

• SPCC Rule;

• Pesticide Managment Regulation;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• UST Rule; and

• Pulp and Paper Effluent Guidelines.

These seven EPA regulations require secondary containment for equipment in order to prevent discharges to jurisdictional waters. Only one regulation, SPCC Rule, allows for active or passive secondary containment. Another four of the seven regulations—MSGP for Industrial Stormwater, SPCC Rule, RCRA TSD Regulations, and Pulp and Paper Effluent Guidelines—allow an alternative to containment to be used to prevent released material from reaching water. For example, MSGP for Industrial Stormwater (2015) allows for a “similarly effective means designed to prevent the discharge of pollutants.”

EPA regulations reviewed vary in their standards for the required secondary containment. For example, RCRA TSD regulations require that secondary containment include at least one of the following: A liner (external to the tank); a vault; a double-walled tank; or an equivalent device as approved by the Regional Administrator. Comparatively, the SPCC Rule requires onshore facilities to use at least one of the following: Dikes, berms, or retaining walls sufficiently impervious to contain oil; curbing or drip pans; sumps and collection systems; culverting, gutters, or other drainage systems; weirs, booms, or other barriers; spill diversion ponds; retention ponds; or sorbent materials. The SPCC Rule requires offshore facilities to use curbing or drip pans or sumps and collection systems.

h. Emergency Response Plan

Eight EPA regulations include requirements for facilities to develop an emergency response plan or at least one of the sub-elements of that program element:

• MSGP for Industrial Stormwater;

• RMP Rule;

• SPCC Rule;

• Pesticide Worker Protection Standard;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• UST Rule; and

• EPCRA Planning Rule.

These eight EPA regulations require either the emergency response program element or at least one of its sub-elements. Of these, four generally require emergency response plans for discharges or accidental releases—RMP Rule, SPCC Rule, RCRA Generators Regulation, and RCRA TSD Regulations. Both RCRA regulations require that facilities develop contingency plans, which describes the actions that must be taken in response to unplanned release of hazardous waste. The SPCC Rule requires that in addition to spill prevention, facilities must include certain response plan elements to assist with a responding to an oil discharge. The RMP Rule requires facilities to develop an emergency response plan for accidental release.

Seven of the eight EPA regulations reviewed for the emergency response plan element require that facilities plan immediate actions in the event of a discharge. For example, the MSGP for Industrial Stormwater regulation requires permitted facilities to develop plans for effective response to spills, including procedures for expeditiously stopping, containing, and cleaning up leaks, spills, and other releases and to execute such procedures as soon as possible. The RMP Plan requires the emergency response plan to include immediate procedures and measures for emergency response after an accident. Four of the reviewed EPA programs also include procedures to ensure personnel safety, such as evacuation. RCRA Generators and TSD Regulations both require evacuation plans for personnel, while the Pesticide Worker Protection Standard requires that employers provide emergency assistance for handlers that have experienced a potential pesticide exposure.

Notification procedures are also frequently addressed by the reviewed EPA regulatory programs. Seven of these EPA regulations have requirements to notify government or local communities about spills. For example, the UST Rule requires owners and operators to notify the implementing agency within 24 hours of a spill. Similarly, the EPCRA Planning Rule requires facilities to make an immediate notification to EPA, as soon as practical, and a written follow-up emergency notification. The RMP Rule requires that emergency response plans include procedures for informing the public and local emergency response agencies about accidental releases.

The remaining sub-elements identified for emergency response planning are addressed by half or less than half of the reviewed EPA regulations. Three programs require medical information, including the RMP Rule which requires documentation of proper first-aid and emergency medical treatment necessary to treat accidental human exposures. Four programs require facilities to designate an emergency response coordinator, including the SPCC Rule which requires the plan to provide a phone number for the facility response coordinator. One program requires facilities to describe information about downstream receptors that may be affected by a discharge. For example, the RMP Rule requires that facilities describe environmental receptors within a calculated distance from the point of release.

i. Coordination of Emergency Response Program With State/Local Responders

Four EPA regulations require facilities to coordinate an emergency response program with state and/or local responders:

• RMP Rule;

• RCRA Generators Regulation;

• RCRA TSD Regulations;

• EPCRA Planning Rule.

Each EPA regulatory program requires facilities to make arrangements with local responders to prepare for an emergency. The RMP Rule mandates that facilities establish an arrangement with public emergency responders to not enter an emergency area except as arranged with the emergency contact indicated in the RMP. The two RCRA rules mandate a coordinated effort with local police, fire, hospital, and other emergency personnel, wherein potential responders understand which specific police/fire departments have primary authority and are familiar with the layout and activity of the facility and the properties of hazardous waste being handled. Unlike the RCRA regulations and RMP Rule, the EPCRA Planning Rule does not require formal arrangements to be made with state and local responders; EPCRA mandates the sharing of information with local emergency response personnel.

4. CWA HS Subject to EPA and Other Federal Regulatory Requirements

EPA further analyzed the existing Federal regulatory programs to determine whether the most frequently discharged CWA HS listed in Table 2 are subject to existing regulatory requirements (Table 6). However, it is important to note that the applicability criteria for some of the regulatory programs do not rely solely on chemical identity, but include other factors (e.g., whether the substance is a waste, the industrial category of the facility); there may be additional regulatory requirements applicable to the identified CWA HS that this analysis has not identified. Thus, in cases where applicability could not be assessed with relative certainty based on chemical identity, the existing regulation was not included in Table 6. Furthermore, the list of CWA HS and/or the criteria for listing or distinguishing hazards between CWA HS is outside the scope of this action, as well as differentiating requirements based on such consideration.

Table 6 summarizes relevant regulations for the most commonly discharged CWA HS. However, there are challenges to identifying applicability for certain programs, specifically when regulatory program applicability relies on criteria other than chemical identity. For example, SMCRA regulations and MSHA regulations apply primarily based on industrial activity (i.e., mining). These requirements were not cited in Table 6, although they may apply to some CWA HS present in those industrial activities. Also, not cited in this table are Standards for Generators of Hazardous Waste; or Standards for Treatment, Storage, and Disposal of Hazardous Waste. Their applicability depends on whether a waste is present, and whether that waste meets the regulatory definition of hazardous waste. While not included in Table 6, these regulations apply to CWA HS in certain situations (e.g., when CWA HS are hazardous waste), so EPA considered these regulatory requirements in the analysis of existing regulations.

For other regulatory programs, applicability may depend on other criteria in addition to chemical identity. Requirements for USTs apply to CWA HS when present in UST systems greater than 110 gallons in capacity. PHMSA Hazardous Materials Regulations specify integrity requirements for packages used to ship hazardous materials, including CWA HS. Therefore, when CWA HS are stored in packages intended for shipment, the packages must meet certain design criteria that may also serve to prevent discharges of CWA HS. These regulatory programs are cited in Table 6, and the complexities of assessing their prevention advantages for CWA HS are discussed in the BID.

Based on the review of NRC reporting data, in conjunction with existing prevention requirements of the regulations included in the analysis, the Agency determined that the majority of identified CWA HS reported discharges to water from non-transportation-related sources have been discharges of chemicals currently subject to discharge or accident prevention regulatory requirements.

C. Conclusions

In the 40 years since CWA section 311(j)(1)(C) was enacted by Congress, multiple statutory and regulatory requirements have been established under different Federal authorities that generally serve to, directly and indirectly, prevent CWA HS discharges. Some states have also established their own discharge prevention provisions relevant to CWA HS. Based on EPA's analysis of the frequency and impacts of reported CWA HS discharges and the existing framework of EPA regulatory programs and implementing regulations, EPA is not proposing additional regulatory requirements at this time.

EPA requests comments on this proposed approach of establishing no new regulatory requirements under the authority of CWA section 311(j)(1)(C). EPA specifically requests comments on the analysis of existing EPA regulations and their applicability to CWA HS for purposes of spill prevention. EPA also requests comments on the analysis of other Federal regulations that supplement the EPA regulatory program analysis and whether EPA should consider expanding the basis of the proposal to these Federal regulations.

Furthermore, while the analysis of state regulations and industry standards included in the BID do not serve as a basis for this proposal, the Agency requests comments on whether the state regulations and industry standards considered have program elements reflective of those identified as key to prevention. The Agency also requests comments on whether there are other Federal regulations not considered in the analysis but that may have applicable discharge prevention requirements, as well as whether any of the identified program elements should or should not have been considered. Likewise, the Agency requests comments on whether there may be regulatory gaps in prevention requirements that are not reflected in the analysis. We also request information that may be used to revise or supplement our analysis regarding any facilities, which are using, storing, producing, and/or otherwise handling CWA HS. Please provide any supporting information, including supporting data, with comments.

IV. Alternative Regulatory Options ConsideredA. Prevention Program

The Agency considered proposing a CWA HS discharge prevention program that would include provisions to address all nine prevention program elements listed in Table 3. Under this option, EPA considered requiring regulated facility owners/operators to develop a written plan with site-specific prevention measures and practices. Regulated facilities would be expected to implement this plan, to maintain and update it as needed, and to make it available for inspection. Under this alternative option, the facilities could take credit for and/or incorporate existing discharge prevention compliance strategies when addressing CWA HS discharge prevention requirements under this program.

A prevention program regulatory option would be designed to reflect all discharge prevention, control and mitigation program elements discussed in this action to prevent and mitigate CWA HS discharges to jurisdictional waters. A prevention program regulatory approach would also include additional administrative program elements, such as requirements to:

• Develop a plan in accordance with good engineering practices;

• Update the plan as operations or equipment changes; and

• Require records documenting compliance with the rule.

Following an analysis of the frequency of CWA HS discharges and the causes and impacts of such discharges, the Agency chose not to propose this approach. Over the 10-year period analyzed (2007-2016), there were a total of 2,491 CWA HS discharges from non-transportation-related sources with 117 of those discharges with reported impacts. This data suggests that the existing framework of regulatory requirements serves to prevent CWA HS discharges.

EPA requests comments on whether to consider this alternative approach and develop a CWA HS prevention program. Comments should include supporting information and data. EPA requests comments on the specific provisions recommended, costs and advantages of such an approach, ways to minimize any regulatory redundancies, and any other information that would support the promulgation of new CWA HS discharge prevention provisions.

B. Targeted Prevention Requirements

EPA also considered proposing a limited set of requirements designed to prevent CWA HS discharges. This regulatory option could establish targeted requirements under one or more of the nine program elements listed in Table 3. Targeted requirements under several of the program elements could be effective in helping to prevent CWA HS discharges.

To evaluate which requirement(s) might be appropriate, EPA reviewed cause data in the NRC database for past CWA HS discharges, and identified four key program elements that may have addressed the CWA HS discharge causes. A summary of this review is shown in Table 7. The first category of causes, Unknown/Illegal Dumping/Other, consisted of reports for which there was either too little information provided to develop a prevention strategy, or for which additional regulatory requirements would be unlikely to prevent the discharges because the HS was disposed of illegally. For example, there are statutory and regulatory prohibitions in place to prevent CWA HS dumping, and these prohibitions are enforced (see CWA section 311(b)(3) and 40 CFR 117.1(a)). There is no reason to believe that a redundant prohibition on such dumping would alleviate the problem of those who already disregard existing regulations.

EPA identified program elements that could be effective in preventing CWA HS discharges resulting from the other four categories of reported causes. These program elements were considered, both individually and in various combinations, as an alternative regulatory option.

Approximately 46 percent of the identified CWA HS discharges from 2007 to 2016 were reportedly due to equipment failure, a natural phenomenon, operator error, or fire/explosion. These causes were all identified as potentially addressed by a hazard review. A requirement to identify potential hazards, including, for example, process hazards, engineering and administrative controls, and human factors, could help prevent CWA HS discharges. However, establishing new requirements for hazard reviews may provide only incremental advantages, as the hazard review program element was identified in seven of the eight EPA regulatory programs and in all four of the other Federal regulations reviewed.

2. Mechanical Integrity

Nearly 23 percent of the identified 2,491 CWA HS discharges from 2007 to 2016 were reportedly due to equipment failure, which could be addressed in part through preventive maintenance. However, EPA believes additional regulatory requirements would provide minimal prevention advantages, since seven of the eight EPA programs and three of the four other Federal programs analyzed in the existing requirements review already contain some mechanical integrity/preventive maintenance provisions.

3. Personnel Training

Approximately 10 percent of the identified 2,491 CWA HS discharges were due to either operator error or fire/explosion, which were both identified as causes that could be reduced by personnel training. Training employees on the proper operation of equipment and discharge prevention measures/procedures could serve to prevent CWA HS discharges due to operator error. However, the value of a personnel training program would depend, in part, on whether proper operating, maintenance, prevention, or response procedures have been developed to train personnel. Personnel training provisions are currently required in seven of the eight EPA programs and three of the four other Federal programs reviewed.

4. Secondary Containment

More than 30 percent of the identified 2,491 CWA discharges were due to causes (e.g., equipment failure, operator failure) where secondary containment could have played a role in preventing the discharge to jurisdictional waters. A requirement to construct and maintain appropriate secondary containment (e.g., sized to prevent a CWA HS discharge from impacting jurisdictional waters could be the most generally applicable program element). However, the advantages of adding secondary containment provisions may only be incremental, as at least some type of secondary containment provision is included in six of the eight EPA regulatory programs and three of the four other Federal regulatory programs reviewed.

5. Conclusion

Provisions for any of the four program elements described above, as well as others identified in Table 3, could be included in a targeted regulatory approach. However, these provisions were frequently identified in both the EPA and other Federal regulatory programs reviewed. EPA believes there would be only minimal incremental value in requiring these provisions in a new regulation. Additionally, the benefits of any of the targeted provisions described above may not justify the associated costs.20 For more information on the potential costs and benefits associated with regulatory options considered for this action, see the economic analysis, “Regulatory Impact Analysis; Clean Water Act Hazardous Substances Discharge Prevention,” available in the docket and the summary of the economic analysis in section V.A. of this action.

20 Executive Order 12866 (58 FR 51735, October 4, 1993) section 1(a) states that in choosing among alternative regulatory approaches, agencies should select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.

EPA requests comments on whether it should adopt a narrowly targeted regulatory approach to prevent CWA HS discharges. Commenters who support targeted prevention requirements should provide information and data that identify which program elements to include and why, the costs and advantages of such an approach, ways to minimize any regulatory redundancies, and any other information that would support the promulgation of new, targeted prevention provisions. Furthermore, EPA requests comments on whether a targeted regulatory approach should allow a facility to substitute alternative prevention measures for specific targeted requirements (e.g., a situation where secondary containment is not practicable, a facility could substitute a separate prevention measure that achieves the same effect).

In summary, the proposal identifies three options the Agency may choose to finalize:

• Establishes no new requirements under the authority of CWA 311(j)(1)(C);

• Requires prevention plans to address the nine program elements discussed; or

• Requires actions under targeted program elements.

EPA requests comments on these three approaches, as well as on other alternatives not specifically identified in this notice. For example, EPA could consider an approach that requires an owner or operator to develop a plan to prevent CWA HS discharges but allows flexibility for the owner or operator to determine what provisions should be incorporated within the plan. The Agency could also consider establishing a prevention program under CWA section 311(j)(1)(C) authority that incorporates existing discharge prevention provisions already established under other statutory authorities. EPA requests comments on alternative approaches.

If the Agency were to finalize an alternative option that establishes a regulatory program, it would apply to facilities producing, storing, processing, using, transferring or otherwise handling CWA HS. EPA would need to establish applicability criteria for the program, and is requesting comments on appropriate applicability criteria or thresholds for such alternatives.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is a significant regulatory action that was submitted to OMB for review, because it raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Any changes made in response to the OMB recommendations have been documented in the docket.

EPA prepared an economic analysis of the potential costs and benefits associated with regulatory options considered for this action. This analysis, “Regulatory Impact Analysis; Clean Water Act Hazardous Substances Discharge Prevention,” is available in the docket.

1. Summary of the Economic Analysis

A regulatory impact analysis (RIA) is included in the record. The RIA considers three alternatives: The proposed no-action approach, a prevention program including provisions under nine program elements, and a targeted approach including four of the program elements. The unit costs of the program elements are derived from similar requirements in other EPA regulatory programs. The number of affected facilities is estimated from the number of facilities subject to EPCRA.

EPA does not attempt to determine the number of potentially regulated facilities currently undertaking various prevention activities in the baseline. Thus, EPA does not estimate total costs per facility, nor does it estimate total program costs across facilities. EPA does calculate the annualized net present value of a wide range of unit compliance costs for each program element over a 10-year analysis period, using 3 percent and 7 percent discount rates, as presented in Tables 8 and 9. Avoided damages, estimated from historical CWA HS discharges, represent the monetized damages. Based on historical incidents reported to the NRC, EPA estimated the total existing level of monetized damages over the 10-year period from 2007 to 2016 to be $33.1 million in 2016 dollars.

EPA believes the benefits would not justify the costs in any alternative other than the proposed alternative.21 The benefits of the provisions are to reduce the likelihood and severity of CWA hazardous substance discharges and their associated impacts on human health and the environment. Table 9 gives estimates of baseline damages from hazardous substance discharges. Annualized damages are estimated as $3.3 million (2016$) and represent human health impacts and evacuations. Nonmonetized baseline damages include impacts such as shelter-in-place events, waterway closures, and lost productivity. The estimated annualized unit costs of proposed provisions vary widely, from less than $100 to tens of thousands of dollars (Table 8). However, existing regulatory programs already require many of the prevention and mitigation actions proposed by Options 2 and 3. Even a robust regulatory program where none existed before would not be expected to completely eliminate all risk.

21 Under Executive Order 12866 (58 FR 51735, October 4, 1993), section 1(b)(6), each agency shall assess both the costs and benefits of the intended regulation and, recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs.

To estimate the universe of facilities that would potentially be subject to a rule preventing CWA HS discharges, EPA first estimated the number of facilities with CWA HS onsite. Information in EPCRA Tier II reports was used to identify facilities with CWA HS onsite, because these reports contain information about many chemicals, of which CWA HS are a subset. EPA reviewed Tier II reports submitted in 16 states and extrapolated the data nationally based on NAICS codes and United States Census data. EPA estimates there are approximately 108,000 potentially affected facilities nationally. For additional details on this methodology, alternatives considered, and the results, please see Section 3 and Appendix B of the RIA available in the docket for this action.22

EPA did not identify an appropriate method to quantify those facilities that would not have the potential to discharge to jurisdictional waters for this action. To estimate the universe of potentially subject facilities, EPA took a conservative approach and assumed that all CWA HS facilities have the potential to discharge CWA HS to jurisdictional waters.

c. Data Limitations

The estimate of potentially regulated facilities has several uncertainties. First, due to the wide range of trade names used for many chemicals and chemical mixtures, it was unclear whether approximately 20 percent of the facilities in the Tier II reports reviewed had a CWA HS onsite. Second, Tier II reports are required for materials present at any one time in an amount greater than or equal to 10,000 pounds, or lower established thresholds for chemicals defined as Extremely Hazardous Substances in 40 CFR part 355, Appendix A. If a proposed regulation were to establish applicability criteria with a higher or lower applicability threshold than those established in 40 CFR part 355, Appendix A, the number of potentially regulated facilities would be impacted. Finally, the extrapolation assumes that the fraction of facilities in each NAICS sector that have CWA HS onsite is the same across all states. As discussed in Section 3.3 of the RIA, alternative extrapolation methodologies were used with reasonably similar results, which provides some confidence that the extrapolation approach is reasonable (i.e., nationwide estimate of approximately 101,000 facilities based on Tier II data and U.S. population vs. approximately 108,000 facilities based on NAICS codes and Census data).

3. Conclusion

EPA seeks comments on the method used to estimate the potential affected universe, including any additional data or information sources that could be used to reduce the uncertainty of the estimate. For any additional information sources, commenters are encouraged to provide information, including where it can be publicly obtained, as well as how the data could improve EPA's current estimate. EPA intends to further refine the estimate of the facilities that could be potentially subject to CWA HS regulatory requirements as additional information is received. EPA is requesting comments on its approach to the economic analysis, including additional sources of information or data to refine the analysis.

This action is not an Executive Order 13771 regulatory or deregulatory action, because this action does not propose any regulatory requirements.

C. Paperwork Reduction Act (PRA)

This action does not impose an information collection burden under the PRA, because this action does not propose any regulatory requirements.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule.

This action proposes no regulatory requirements. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.

F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications as specified in Executive Order 13175, because this action proposes no regulatory requirements. Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in Section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

I. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action proposes no regulatory requirements.

EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard and imposes no regulatory requirements.

Hawaii has applied to the Environmental Protection Agency (EPA) for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act, as amended (RCRA). These changes correspond to certain federal rules promulgated between May 26, 1998 and June 30, 2016 (also known as RCRA Checklist 167 and Clusters IX through XXIV) plus several changes initiated by the State. EPA has reviewed Hawaii's application with regards to federal requirements and is proposing to authorize the changes. The EPA seeks public comment prior to taking final action.

DATES:

Comments on this proposed rule must be received by July 25, 2018.

ADDRESSES:

Submit your comments, identified by Docket ID Number EPA-R09-RCRA-2018-0267 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the federal program. As the federal program changes, states must change their programs and ask EPA to authorize the changes. Changes to state programs may be necessary when federal or state statutory or regulatory authority is modified or when certain other changes occur. Most commonly, states must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.

B. What decisions has EPA made in this rule?

On December 13, 2017, Hawaii submitted a final complete program revision application seeking authorization of changes to its hazardous waste program corresponding to certain federal rules promulgated between May 26, 1998 and June 30, 2016 (also known as RCRA Checklist 167 and Clusters IX through XXIV) plus several changes initiated by the State. EPA concludes that Hawaii's application to revise its authorized program meets all statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA proposes to grant Hawaii final authorization to operate as part of its hazardous waste program the changes listed below in Section F of this document, as further described in the authorization application.

Hawaii has responsibility for permitting treatment, storage, and disposal facilities within its borders and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA).

C. What is the effect of today's authorization decision?

The effect of this decision is that the changes described in Hawaii's authorization application will become part of the authorized state hazardous waste program, and therefore will be federally enforceable. Hawaii will continue to have primary enforcement authority and responsibility for its state hazardous waste program. EPA retains its authorities under RCRA sections 3007, 3008, 3013, and 7003, including its authority to:

• Enforce RCRA requirements, including authorized state program requirements, and suspend or revoke permits; and

• Take enforcement actions regardless of whether the state has taken its own actions.

This action does not impose additional requirements on the regulated community because the regulations for which Hawaii is being authorized by today's action are already effective, and are not changed by today's action.

D. What happens if EPA receives comments that oppose this proposed action?

EPA will consider all comments received during the comment period and address all such comments in a final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so during the comment period for this proposed rule.

E. For what has Hawaii previously been authorized?

Hawaii initially received final authorization to implement its base hazardous waste management program including federal program revisions through May 25, 1998 (Cluster VIII partial) on November 13, 2001 (66 FR 55115). Since initial authorization Hawaii has not applied for or received authorization for revisions to its hazardous waste program.

F. What changes is EPA proposing with today's action?

Hawaii has applied to EPA for authorization of changes to its hazardous waste program that correspond to certain federal rules promulgated between May 25, 1998 and July 1, 2016 (also known RCRA Cluster VIII through XXIV) and for authorization of state-initiated changes that are equivalent to or more stringent than the federal program.

EPA proposes to determine, subject to public review and comment, that Hawaii's hazardous waste program revisions as described in the State's authorization revision application dated November 22, 2017 are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all the requirements necessary to qualify for final authorization. Regulatory revisions that are less stringent than the Federal program requirements and those regulatory revisions that are broader in scope than the Federal program requirements are not authorized. Accordingly, EPA proposes to grant Hawaii final authorization for the program changes described below.

Hawaii has revised the format of its hazardous waste regulations from verbatim adoption to incorporation by reference of the Federal hazardous waste management regulations into their counterpart Hawaii Administrative Rules (HAR). HAR chapter 11-280 has been repealed without replacement. The requirements for public availability of information (RCRA § 3006(f)) previously found in 11-280 are met by HAR chapters 2-71 and 11-1, HRS chapter 92F and sections 342J-14 and 342J-14.5, and provisions adopted from Federal rules (40 CFR 260.2) in HAR chapter 11-260.1.

The repeal of the verbatim adoption of the Federal program in HAR Title 11 chapters 260, 261, 262, 263, 264, 265, 266, 268, 270, 271, 273, 279, and 280 is replaced by incorporation by reference (“IBR”) into HAR Title 11 chapters 260.1, 261.1, 262.1, 263.1, 264.1, 265.1, 266.1, 268.1, 270.1, 271.1, 273.1, and 279.1 and are effective July 17, 2017. The applicable Federal rules and analogous State rules are identified in the table below.

Under RCRA § 3009, the EPA may not authorize state rules that are less stringent than the Federal program. Any state rules that are less stringent do not supplant the federal regulations. State rules that are broader in scope than the Federal program requirements are allowed but do not become part of the enforceable federal program. State rules that are equivalent to or more stringent than the federal program may be authorized, in which case they are enforceable by the EPA.

This section does not discuss the program differences previously published in Hawaii's base program authorization in 2001, at 66 FR 55115 (November 1, 2001). Areas identified in the base program authorization as more stringent or broader in scope than the federal program have been carried forward into the new regulations as amendments or additions to the incorporation by reference of the federal regulations. This section discusses new State requirements that are more stringent, or new requirements that are broader in scope and cannot be authorized.

1. More Stringent

States may seek authorization for state requirements that are more stringent than federal requirements. The EPA has the authority to authorize and enforce those parts of a state's program the EPA finds to be more stringent than the federal program. This section does not discuss each more stringent finding made by the EPA, but rather rules of particular interest that were not previously described in 2001, available at 66 FR 55115, November 1, 2001. Persons should consult the docket for this rule, including Hawaii's revised Program Description, dated May 1, 2018 for a complete list of rules determined to be more stringent than federal rules.

i. More stringent regulation of specific wastes

a. Solvent-Contaminated Wipes: Hawaii is adopting the conditional exclusions for solvent-contaminated wipes addressed by Revision Checklist 229, but is adding one additional condition to the incorporated version of 40 CFR 261.4(a)(26) and 261.4(b)(18): Containers in which solvent-contaminated wipes eligible for the exclusion are being accumulated must be labeled with the accumulation start date.

b. Spent lead-acid batteries: Hawaii regulates persons who generate, transport, collect, or store spent-lead acid batteries sent for reclamation (other than through regeneration) as handlers/transporters of universal waste under chapter 11-273.1. This is more stringent than the federal program, which exempts these groups from many regulations under 40 CFR 266.80.

ii. Notification before cancellation of certain financial assurance instruments. Hawaii requires hazardous waste treatment, storage, and disposal facilities, and reclamation and intermediate facilities managing hazardous secondary materials, to notify both the State Director and the Regional Administrator before cancellation of certain financial assurance instruments. The federal regulations require only one authority to be notified, so the requirement to notify the Regional Administrator in addition to the State Director is more stringent than the federal regulation. This applies to surety bonds, letters of credit, corporate guarantees, liability endorsements, certificates of liability insurance, and standby letters of credit (Incorporated version of 40 CFR 261.151(b), (c), (g), (h), (i), (j), (k), 264.151(b), (c), (d), (h), (i), (j), (k), and (l)).

iii. Used oil processor facility standards: The State does not allow for exceptions to the requirement that used oil processors have emergency equipment listed in 40 CFR 279.52(a)(2). The State also does not allow for the possibility that aisle space required in 279.52(a)(5) is not necessary.

iv. Notification in case of emergency. Hawaii requires notification of emergencies to the State Hazard Evaluation and Emergency Response (HEER) office designated on-scene coordinator in addition to the National Response Center (NRC) for: Facilities handling secondary hazardous materials (HSM), generators of hazardous waste, transporters of hazardous waste and used oil, treatment, storage, and disposal facilities and used oil processors.

v. Recordkeeping requirements. The State requires the following additional recordkeeping requirements:

a. Generator container storage area inspection log: Generators must keep a log of the weekly container storage area inspections.

b. Universal waste transporters: Universal waste transporters must maintain the same type of records that Large Quantity Handlers of Universal Waste and Destination Facilities must maintain. Records must be maintained for three years.

c. Used oil generators: Used oil generators must keep records of shipments, similar to the records required for used oil transporters under the federal program. These records must be maintained for three years.

d. Used oil processors: Used oil processors must keep records of the equipment testing and maintenance required by 40 CFR 279.52(a)(3) (in the incorporated version of 279.57(a)(2)).

vi. Permits: The State limits the duration of Remedial Action Plans to five years instead of ten (40 CFR 270.195).

vii. No standard permit option: The State has not adopted federal regulations allowing standardized permits.

viii. Used oil management.

a. Used oil testing: The State requires that used oil transporters and processors make a hazardous waste determination for used oil sent for disposal. The State regulations allow used oil burners and marketers to either test used oil for halogens or obtain results of tests performed by the processor.

b. Annual reporting for used oil processors: The State requires used oil processors to submit an annual report of used oil activities by July 31. The content of the report is similar to the biennial report required in the federal program and replaces the used oil biennial reporting requirement (40 CFR 279.57(b)).

ix. Alternative groundwater monitoring plans. The State has added a requirement that any interim status facility opting for an alternative groundwater monitoring plan under the incorporated version of 40 CFR 265.90(d) submit a copy of the plan to the department, in addition to maintaining the plan on-site at the facility.

x. Notification of newly regulated hazardous waste activity. State regulations (HRS 342J-6.5) require generators, transporters, and owners or operators of treatment, storage, or disposal facilities newly regulated due to a change in the definition of hazardous waste (HAR chapter 11-261.1) to submit a notification within 45 days of the regulatory revision (rather than the federal requirement of 90 days) (40 CFR 270.1(b)).

xi. Academic laboratory generator standards: The State is not adopting the alternative requirements for hazardous waste determination and accumulation of unwanted materials at academic laboratories, (73 FR 72912, December 1, 2008 and 75 FR 79304, December 20, 2010).

xii. Used oil storage requirements: The State has added language to the incorporated version of 40 CFR 279.22, 279.45, 279.54, 279.64, to clarify that containers and aboveground tanks storing used oil must be kept closed.

2. Areas Where the State Program Is Broader in Scope

i. Coal combustion residuals: The State is not adopting the Federal final rule that added a list of coal combustion residuals to 40 CFR 261.4(b)(4)(ii) to the ash and other waste types from coal combustion that were already included in an exemption from the definition of hazardous waste, if these residuals are co-disposed with the waste types originally listed (80 FR 21302-21501, October 19, 2015). Hawaii does not exclude these waste types from the definition of solid waste.

ii. Cathode Ray Tubes and Carbon Dioxide Streams in Geological Sequestration Activities: Hawaii is not adopting the Federal final rules that introduced and/or revised conditional exclusions for (1) Cathode Ray Tubes (CRTs) from the definition of solid waste (40 CFR 261.4(a)(22)) and (2) carbon dioxide (CO2) streams in geological sequestration activities from the definition of hazardous waste (at 40 CFR 261.4(h)). Hawaii program is broader in scope so long as all the conditions of the Federal exclusion are met.

3. Universal Waste: Electronic Item Added

The State has added a category of universal waste to HAR chapter 11-273.1 called “electronic items” and defined waste management and labeling/marking requirements for this type of universal waste. The State determined, based on extensive research, that most waste electronic items are toxicity characteristic hazardous wastes due to the presence and concentration of one or more metals (e.g. lead, cadmium) and may also contain other dangerous constituents, such as a brominated (flame retardant) plastics. The State also determined that electronic items (as defined in HAR chapters 11-260.1 and 11-273.1) as a category meet the criteria of 40 CFR 273.81. EPA allows authorized States to create regulations for State-only universal wastes provided that these criteria are met for the waste or waste category, including the key requirements that universal waste management is sufficiently protective of human health and the environment and that regulation as universal waste increases the likelihood of similar unregulated wastes (such as CESQG or household wastes) being diverted from non-hazardous to hazardous waste management systems.

4. Procedural Rules

i. Contested case hearings and declaratory orders: The State's previous regulations governing contested case hearings (HAR chapter 11-271 subchapter B, based on 40 CFR part 22) and declaratory rulings (HAR chapter 11-271 subchapter C) for the hazardous waste program have been repealed. The State Department of Health has similar department-wide procedures for case hearings and declaratory orders that now apply (HAR chapter 11-1). The State is not adopting an equivalent to 40 CFR 124.19 and instead adds procedures for requesting a contested case hearing in the incorporated version of 40 CFR 124.15 in HAR chapter 11-271.1.

ii. Public availability of information: The State's previous regulations regarding public availability of information and treatment of confidential business information (HAR chapter 11-280) have been repealed. Requests for public information will be handled under HRS 342J-14 and 342J-14.5 and applicable provisions of HRS chapter 92F and HAR chapter 2-71, which are referenced in the incorporated version of 40 CFR 260.2. EPA determines that Hawaii's requirements for public availability of information and treatment of confidential business information are substantially similar to EPA's federal regulations.

Other than the differences discussed above, Hawaii incorporates by reference the remaining federal rules listed in Section F; therefore, there are no significant differences between the remaining federal rules and the revised state rules being authorized today.

H. Who handles permits after the authorization takes effect?

Hawaii will continue to issue permits for all the provisions for which it is authorized and will administer the permits it issues. Section 3006(g)(1) of RCRA, 42 U.S.C. 6926(g)(1), gives EPA the authority to issue or deny permits or parts of permits for requirements for which the State is not authorized. Therefore, whenever EPA adopts standards under HSWA for activities or wastes not currently covered by the authorized program, EPA may process RCRA permits in Hawaii for the new or revised HSWA standards until Hawaii has received final authorization for such new or revised HSWA standards.

I. What is codification and is EPA codifying Hawaii's hazardous waste program as authorized in this rule?

Codification is the process of placing the state's statutes and regulations that comprise the state's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by referencing the authorized state rules in 40 CFR part 272. EPA is not codifying the authorization of Hawaii's changes at this time. However, EPA reserves the amendment of 40 CFR part 272, subpart M for this authorization of Hawaii's program changes until a later date.

J. Administrative Requirements

The Office of Management and Budget (OMB) has exempted this action (RCRA State authorization) from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). This action authorizes state requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by state law. Therefore, this action is not subject to review by OMB. This action is not an Executive Order 13771 (82 FR 9339, February 3, 2017) regulatory action because actions such as this proposed authorization of Hawaii's revised hazardous waste program under RCRA are exempted under Executive Order 12866. This action will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes state requirements as part of the state RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

Under RCRA 3006(b), the EPA grants a State's application for authorization, as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for the EPA, when it reviews a state authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, the EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. The EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the Executive Order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. Because this rule authorizes pre-existing state rules which are at least equivalent to, and no less stringent than existing federal requirements, and impose no additional requirements beyond those imposed by state law, and there are no anticipated significant adverse human health or environmental effects, the rule is not subject to Executive Order 12898. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this document and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action nevertheless will be effective 60 days after the final approval is published in the Federal Register.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Lisa O. Wilson, (410) 786-8852.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

I. Introduction

The Department of Health and Human Services (HHS) is working to transform the healthcare system into one that pays for value. Care coordination is a key aspect of systems that deliver value. Removing unnecessary government obstacles to care coordination is a key priority for HHS. To help accelerate the transformation to a value-based system that includes care coordination, HHS has launched a Regulatory Sprint to Coordinated Care, led by the Deputy Secretary. This Regulatory Sprint is focused on identifying regulatory requirements or prohibitions that may act as barriers to coordinated care, assessing whether those regulatory provisions are unnecessary obstacles to coordinated care, and issuing guidance or revising regulations to address such obstacles and, as appropriate, encouraging and incentivizing coordinated care.

The Centers for Medicare & Medicaid Services (CMS) has made facilitating coordinated care a top priority and seeks to identify ways in which its regulations may impose undue burdens on the healthcare industry and serve as obstacles to coordinated care and its efforts to deliver better value and care for patients. Through internal discussion and input from external stakeholders, CMS has identified some aspects of the physician self-referral law as a potential barrier to coordinated care. Addressing unnecessary obstacles to coordinated care, real or perceived, caused by the physician self-referral law is one of CMS's goals in this Regulatory Sprint. To inform our efforts to assess and address the impact and burden of the physician self-referral law, including whether and, if so, how it may prevent or inhibit care coordination, we welcome public comment on the physician self-referral law and, in particular, comment on the questions presented in this Request for Information (RFI).

II. Background

When enacted in 1989, the physician self-referral law (section 1877 of the Social Security Act), also known as the “Stark Law,” addressed the concern that health care decision making can be unduly influenced by a profit motive. When physicians have a financial incentive to refer patients for health care services, this incentive may affect utilization, patient choice, and competition. Overutilization may occur when items and services are ordered that would not have been ordered absent a profit motive. A patient's choice can be affected when he or she is steered to less convenient, lower quality, or more expensive providers of health care that are sharing profits with, or providing other remuneration to, the referring practitioner. Where referrals are controlled by those sharing profits or receiving other remuneration, the medical marketplace suffers since new competitors may have more difficulty generating business on superior quality, service, or price alone.

By design, the physician self-referral law is intended to disconnect a physician's health care decision making from his or her financial interests in other health care providers and suppliers. Specifically, the law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The prohibitions are absolute unless the physician's referral is permitted under an enumerated exception. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse. For more information, please refer to the CMS physician self-referral website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/index.html?redirect=/PhysicianSelfReferral/.

CMS is aware of the effect the physician self-referral law may have on parties participating or considering participation in integrated delivery models, alternative payment models, and arrangements to incent improvements in outcomes and reductions in cost. The President's Budget for fiscal year (FY) 2019 included a legislative proposal to establish a new exception to the physician self-referral law for arrangements that arise due to participation in alternative payment models. In addition to this legislative proposal, CMS has engaged stakeholders through comment solicitations in several recent rulemakings. In 2017, through the annual payment rules, CMS asked for comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. In response, commenters shared additional information regarding the barriers to participation in health care delivery and payment reform efforts, both public and private, as well as the burdens of compliance with the physician self-referral law and our regulations as they exist today. As a result of our review of these comments, and with a goal of reducing regulatory burden and dismantling barriers to value-based care transformation, while also protecting the integrity of the Medicare program, we are requesting additional information in this RFI. We are particularly interested in your thoughts on issues that include, but are not limited to, the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law. We look forward to receiving your input on this RFI.

III. Request for Information

We are requesting public input on the following areas:

1. Please tell us about either existing or potential arrangements that involve DHS entities and referring physicians that participate in alternative payment models or other novel financial arrangements, whether or not such models and financial arrangements are sponsored by CMS. Please include a description of the alternative payment model(s) and novel financial arrangements if not sponsored by CMS. We recommend that you identify concerns regarding the applicability of existing exceptions to the physician self-referral law and/or the ability of the arrangements to satisfy the requirements of an existing exception, as well as the extent to which the physician self-referral law may be impacting commercial alternative payment models and novel financial arrangements. Please be specific regarding the terms of the arrangements with respect to the following:

• The categories/types of parties (for example, the parties are a hospital and physician group with downstream payments to individual physicians in the group).

• Which parties bear risk (and how and to what extent) under the arrangement (for example, per capita payments from a payor are paid to a hospital with downstream payments on a discounted fee schedule to individual physicians; a bundled payment from a payor for all hospital and physician services is split between a hospital and physicians based on a predetermined percentage; hospital-sponsored gainsharing program where participating physicians share in cost savings; physician incentive payments are available for achieving predetermined metrics; etc.).

• The scope of the arrangement (for example, non-Medicare beneficiaries only, Medicare beneficiaries only, or all patients regardless of payor).

• The timeframe of the arrangement (for example, ongoing or for a duration that aligns with a payor-specific initiative).

• How the arrangement furthers the purpose of the alternative payment model or novel financial arrangement.

• Whether and, if so, how the arrangement mitigates the financial incentives for inappropriate self-referrals, and/or overutilization of items and services, and patient choice.

2. What, if any, additional exceptions to the physician self-referral law are necessary to protect financial arrangements between DHS entities and referring physicians who participate in the same alternative payment model? Specifically—

4. Please share your thoughts on the utility of the current exception at 42 CFR 411.357(n) for risk-sharing arrangements.

5. Please share your thoughts on the utility of the special rule for compensation under a physician incentive plan within the exception at 42 CFR 411.357(d) for personal service arrangements.

6. Please share your thoughts on possible approaches to address the application of the physician self-referral law to financial arrangements among participants in alternative payment models and other novel financial arrangements. Consider the following:

• Would a single exception provide sufficient protection for all types of financial arrangements?

• Would a multifaceted approach that amends existing exceptions and/or establishes new exceptions be preferable?

• Would such a multifaceted approach sufficiently allow parties to identify and satisfy the requirements of one (or more) applicable exceptions in order to protect individual DHS referrals, ownership or investment interests, and/or compensation arrangements?

7. In the context of health care delivery, payment reform, and the physician self-referral law, please share your thoughts on definitions for critical terminology such as—

8. Please identify and suggest definitions for other terminology relevant to the comments requested in this RFI.

9. Please share your thoughts on possible approaches to defining “commercial reasonableness” in the context of the exceptions to the physician self-referral law.

10. Please share your thoughts on possible approaches to modifying the definition of “fair market value” consistent with the statute and in the context of the exceptions to the physician self-referral law.

11. Please share your thoughts on when, in the context of the physician self-referral law, compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.

12. Please share your thoughts on when, in the context of alternative payment models and other novel financial arrangements, compensation should be considered to “take into account the volume or value of referrals” by a physician or “take into account other business generated” between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.

13. Please share your thoughts regarding whether and, if so, what barriers exist to qualifying as a “group practice” under the regulations at 42 CFR 411.352.

14. Please share your thoughts on the application and utility of the current exception at 42 CFR 411.357(g) for remuneration unrelated to DHS. Specifically, how could CMS interpret this exception to cover a broader array of arrangements?

15. Please identify any provisions, definitions, and/or exceptions in the regulations at 42 CFR 411.351 through 411.357 for which additional clarification would be useful.

16. Please share your thoughts on the role of transparency in the context of the physician self-referral law. For example, if provided by the referring physician to a beneficiary, would transparency about physician's financial relationships, price transparency, or the availability of other data necessary for informed consumer purchasing (such as data about quality of services provided) reduce or eliminate the harms to the Medicare program and its beneficiaries that the physician self-referral law is intended to address?

17. Please share your thoughts on whether and how CMS could design a model to test whether transparency safeguards other than those currently contained in the physician self-referral law could effectively address the impact of financial self-interest on physician medical decision-making.

19. Please identify any recent studies assessing the positive or negative effects of the physician self-referral law on the healthcare industry. To the extent publicly available, please provide a copy of the study(ies).

20. Please share your thoughts regarding whether CMS should measure the effectiveness of the physician self-referral law in preventing unnecessary utilization and other forms of program abuse relative to the cost burden on the regulated industry and, if so, how CMS could estimate this.

Respondents are encouraged to provide complete but concise and organized responses, including any relevant data and specific examples. However, respondents are not required to address every issue or respond to every question discussed in this RFI to have their responses considered. In accordance with the implementing regulations of the Paperwork Reduction Act at 5 CFR 1320.3(h)(4), all responses will be considered provided they contain information CMS can use to identify and contact the commenter, if needed.

Please note, this is a request for information only. As previously stated, respondents are encouraged to provide complete but concise responses. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), application, proposal abstract, or quotation. This RFI does not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, CMS is not seeking proposals through this RFI and will not accept unsolicited proposals. Respondents are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request. Please note that CMS will not respond to questions about the policy issues raised in this RFI. CMS may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI responses.

Responses to this RFI are not offers and cannot be accepted by the U.S. Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the U.S. Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur costs for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. CMS may publicly post the comments received, or a summary thereof.

IV. Collection of Information Requirements

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. However, section III. of this document does contain a general solicitation of comments in the form of a request for information. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

IV. Response to Comments

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we may respond to the comments in the preamble to that document.

The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments regarding this information collection received by July 25, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@OMB.EOP.GOV or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

Animal and Plant Health Inspection Service

Title: Importation of Gypsy Moth Host Materials from Canada.

OMB Control Number: 0579-0142.

Summary of Collection: The United States Department of Agriculture (USDA) is responsible for preventing plant diseases or insect pests from entering the United States, preventing the spread of pests not widely distributed in the United States, and eradicating those imported pests when eradication is feasible. Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to regulate the importation of plants, plant products, and other articles to prevent the introduction of injurious plant pests. The Plant Protection and Quarantine program within USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for ensuring that these regulations are enforced.

Need and Use of the Information: APHIS will collect information from individuals both within and outside the United States using phytosanitary certificates, certificates of origin, a written statement, a compliance agreement and an emergency Action notice. Information collected will ensure that importing foreign logs, trees, shrubs, and other articles do not harbor plant or insect pests such as the gypsy moth. Failing to collect this information would cripple APHIS' ability to ensure that trees, shrubs, logs, and a variety of other items imported from Canada do not harbor gypsy moths.

Description of Respondents: Business or other for-profit; Individuals or households; Federal Government.

Number of Respondents: 2,526.

Frequency of Responses: Reporting: On occasion.

Total Burden Hours: 212.

Animal and Plant Health Inspection Service

Title: Importation of Clementines from Spain.

OMB Control Number: 0579-0203.

Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to regulate the importation of plants, plant products, and other articles to prevent the introduction of injurious plant pests. The regulations in “Subpart—Fruits and Vegetables,” 7 CFR 319.56 through 319.56-81, prohibits or restrict the importation of certain fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pest, including fruit flies. Under the regulations, clementines from Spain are subject to certain conditions before entering the United States to ensure that exotic plant pest, such as the Mediterranean fruit fly, are not introduced into the United States.

Need and Use of the Information: APHIS uses the following information collection activities to allow the importation of Clementines from Spain when the requirements include: Provisions that the Clementines be grown in accordance with a Mediterranean fruit fly management program established by the Government of Spain; Trapping and Control Records; Phytosanitary Certificate; Labeling and Traceback; Cold Treatment Data for Consignments; Trust Fund Agreement; Grower Registration and Agreement; Management Program Mediterranean Fruit Fly Monitoring; Cold Treatment Facility/Carrier Certification; Workplan, Advance Reservations for Cold Treatment Port Space; and Emergency Action Notification.

Failure to collect this information would cripple APHIS' ability to ensure that clementines from Spain are not carrying fruit flies.

Description of Respondents: Business or other for-profit; Federal Government.

Number of Respondents: 23.

Frequency of Responses: Recordkeeping; Reporting: On occasion.

Total Burden Hours: 8,774.

Animal and Plant Health Inspection Service

Title: Importation of Longan from Taiwan.

OMB Control Number: 0579-0351.

Summary of Collection: Under the Plant Protection Act (7 U.S.C 7701), the Secretary of Agriculture is authorized to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests new to the United States or not known to be widely distributed throughout the United States. The fruits and vegetables regulations allow the importation of commercial shipments of fresh longan with stems from Taiwan into the United States. As a condition of entry, the longan will be subject to cold treatment and special port-of-arrival inspection procedures for certain quarantine pests.

Need and Use of the Information: APHIS will use the following information collection activities to allow the import of commercial shipment of fresh longan with stems from Taiwan into the United States: Phytosanitary Certificate, Inspection by NPPOs in Taiwan, Stamping of Boxes and Emergency Action Notification. Failing to collect this information would cripple APHIS ability to ensure that longan from Taiwan are not carrying plant pests.

Description of Respondents: Business or other for-profits; Federal Government.

Number of Respondents: 2.

Frequency of Responses: Reporting: On occasion.

Total Burden Hours: 33.

Animal and Plant Health Inspection Service

Title: Importation of Fresh Pitaya Fruit from Central America into the Continental United States.

OMB Control Number: 0579-0378.

Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary of Agriculture is authorized to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests new to the United States or not known to be widely distributed throughout the United States. The regulations “Subpart-Fruit and Vegetables” (7 CFR 319.56-1 through 319 56-71), prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are not widely distributed within the United States. The Animal and Plant Health Inspection Service (APHIS) allows the importation of fresh pitaya fruit from Central America into the continental United States.

Need and Use of the Information: The Animal and Plant Health Inspection Service uses the following activities to collect information: Production Site Certification, Production Site Registration, Review and Maintain Documents, Registration of Packinghouses, Packinghouse Inspections and Investigations, Bilateral Workplans, Records of Fruit Fly Detections and Update Records, Shipping Documents Identifying the Places of Production, Phytosanitary Certificates with Additional Declarations, Box Markings, Production Site Training Program, Emergency Action Notifications, and Notices of Arrival. If the information is not collected, APHIS' ability to protect the United States from plant pest would be severely compromised.

Description of Respondents: Business or other for-profit; Federal Government.

The Rural Housing Service (RHS), an Agency within Rural Development, announces that it is soliciting competitive applications under its Housing Preservation Grant (HPG) program. This action is taken to comply with Agency regulations which requires the Agency to announce the opening and closing dates for receipt of pre-applications for HPG funds from eligible applicants.

The Agency has published the amount of funding received in the Consolidated Appropriations Act, 2018 (Pub. L. 115-141, March 23, 2018) on its website at https://www.rd.usda.gov/newsroom/notices-solicitation-applications-nosas. Expenses incurred in developing applications will be at the applicant's risk.

DATES:

The closing deadline for receipt of all pre-applications in response to this Notice is 5:00 p.m., local time for each Rural Development State Office on August 9, 2018 regardless of delivery method (hand delivered, electronic, mail, or a combination thereof). Rural Development State Office locations can be found at: http://www.rd.usda.gov/contact-us/state-offices. RHS will not consider any application that is received after the closing deadline. Applicants intending to mail applications must provide sufficient time to permit delivery on or before the closing deadline date and time. Acceptance by the United States Postal Service or private mailer does not constitute delivery. Facsimile (FAX) and postage due applications will not be accepted.

The Agency encourages applications that will help improve life in rural America. See information on the Interagency Task Force on Agriculture and Rural Prosperity found at www.usda.gov/ruralprosperity. Applicants are encouraged to consider projects that provide measurable results in helping rural communities build robust and sustainable economies through strategic investments in infrastructure, partnerships and innovation. Key strategies include:

The reporting requirements contained in this Notice have been approved by the Office of Management and Budget under Control Number 0575-0115.

A. Program Description

The HPG program is a grant program, authorized under 42 U.S.C. 1490m and implemented at 7 CFR part 1944, subpart N, which provides qualified public agencies, private non-profit organizations including, but not limited to, Faith-Based and neighborhood partnerships, and other eligible entities, grant funds to assist low- and very low-income homeowners in repairing and rehabilitating their homes in rural areas. In addition, the HPG program assists rental property owners and cooperative housing complexes in rural areas in repairing and rehabilitating their units if they agree to make such units available to low- and very low-income persons.

B. Federal Award Information

The funding instrument for the HPG program will be a grant agreement. The term of the grant can vary from 1 to 2 years, depending on available funds and demand. No maximum or minimum grant levels have been established at the National level. In accordance with 7 CFR 1944.652, coordination and leveraging of funding for repair and rehabilitation activities with housing and community development organizations or activities operating in the same geographic area are expected, but not required. You should contact the Rural Development State Office to determine the allocation. HPG applicants who were previously selected for HPG funds are eligible to submit new applications to apply for Fiscal Year (FY) 2018 HPG program funds. New HPG applications must be submitted for the renewal or supplementation of existing HPG repair and/or rehabilitation projects that will be completed with FY 2018 HPG funds.

The amount of funding available for the HPG program may be found at the following link: http://www.rd.usda.gov/programs-services/housing-preservation-grants. Priorities such as Rural Economic Area Partnership Zones and other funds will be distributed under a formula allocation to states pursuant to 7 CFR part 1940, subpart L, “Methodology and Formulas for Allocation of Loan and Grant Program Funds.” Decisions on funding will be based on pre-application scores. Anyone interested in submitting an application for funding under this program is encouraged to consult the Rural Development website periodically for updated information regarding the status of funding authorized for this program.

The commitment of program dollars will be made to selected applicants that have fulfilled the necessary requirements for obligation.

C. Eligibility Information

1. Eligible Applicants. Eligible entities for these competitively awarded grants include State and local Governments, non-profit corporations, which may include, but not be limited to Faith-Based and community organizations, federally recognized Indian Tribes, and consortia of eligible entities. HPG applicants who were previously selected for HPG funds are eligible to submit new applications to apply for FY 2018 HPG program funds. More eligibility requirements can be found at 7 CFR 1944.658, 1944.661, and 1944.662.

2. Cost Sharing or Matching. Pursuant to 7 CFR 1944.652, grantees are expected to coordinate and leverage funding for repair and rehabilitation activities, as well as replacement housing, with housing and community development organizations or activities operating in the same geographic area. While HPG funds may be leveraged with other resources, cost sharing or matching is not a requirement for the HPG applicant as the HPG applicant would not be denied an award of HPG funds if all other project selection criteria have been met.

3. Other. Awards made under this Notice are subject to the provisions contained in the Consolidated Appropriations Act, 2018 (Pub. L. 115-141, March 23, 2018) sections 745 and 746 regarding corporate felony convictions and corporate Federal tax delinquencies. To comply with these provisions, only applicants that are or propose to be corporations will submit this form as part of their pre-application. Form AD-3030 can be found here: http://www.ocio.usda.gov/document/ad3030.

D. Application and Submission Information

1. Address to Request Application Package: Applicants wishing to submit a paper application in response to this Notice must contact the Rural Development State Office serving the State of the proposed HPG housing project in order to receive further information and copies of the paper application package. You may find the addresses and contact information for each State Office following this web link, http://www.rd.usda.gov/contact-us/state-offices. Rural Development will date and time stamp incoming paper applications to evidence timely receipt and, upon request, will provide the applicant with a written acknowledgment of receipt. You may access the electronic grant pre-application for Housing Preservation Grants at: http://www.grants.gov.

2. Content and Form of Application: 7 CFR part 1944, subpart N provides details on what information must be contained in the pre-application package. Entities wishing to apply for assistance should contact the Rural Development State Office to receive further information, the State allocation of funds, and copies of the pre-application package. Unless otherwise noted, applicants wishing to apply for assistance must make its statement of activities available to the public for comment. The applicant(s) must announce the availability of its statement of activities for review in a newspaper of general circulation in the project area and allow at least 15 days for public comment. The start of this 15-day period must occur no later than 16 days prior to the last day for acceptance of pre-applications by the U.S. Department of Agriculture (USDA)-Rural Development. Federally recognized Indian Tribes, pursuant to 7 CFR 1944.674, are exempt from the requirement to consult with local leaders including announcing the availability of its statement of activities for review in a newspaper.

All applicants will file an original and two copies of Standard Form (SF) 424, “Application for Federal Assistance,” and supporting information with the appropriate Rural Development State Office. A pre-application package, including SF-424, is available in any Rural Development State Office. All pre-applications shall be accompanied by the following information which Rural Development will use to determine the applicant's eligibility to undertake the HPG program and to evaluate the pre-application under the project selection criteria of 7 CFR 1944.679.

(a) A statement of activities proposed by the applicant for its HPG program as appropriate to the type of assistance the applicant is proposing, including:

(1) A complete discussion of the type of and conditions for financial assistance for housing preservation, including whether the request for assistance is for a homeowner assistance program, a rental property assistance program, or a cooperative assistance program;

(2) The process for selecting recipients for HPG assistance, determining housing preservation needs of the dwelling, performing the necessary work, and monitoring/inspecting work performed;

(3) A description of the process for coordinating with other public and private organizations and programs that provide assistance in rehabilitation of historic properties in accordance with 7 CFR 1944.673;

(4) The development standard(s) the applicant will use for the housing preservation work; and, if not the Rural Development standards for existing dwellings, the evidence of its acceptance by the jurisdiction where the grant will be implemented;

(5) The time schedule for completing the program;

(6) The staffing required to complete the program;

(7) The estimated number of very low- and low-income minority and nonminority persons the grantee will assist with HPG funds; and, if a rental property or cooperative assistance program, the number of units and the term of restrictive covenants on their use for very low- and low-income;

(8) The geographical area(s) to be served by the HPG program;

(9) The annual estimated budget for the program period based on the financial needs to accomplish the objectives outlined in the proposal. The budget should include proposed direct and indirect administrative costs, such as personnel, fringe benefits, travel, equipment, supplies, contracts, and other cost categories, detailing those costs for which the grantee proposes to use the HPG grant separately from non-HPG resources, if any. The applicant budget should also include a schedule (with amounts) of how the applicant proposes to draw HPG grant funds, i.e., monthly, quarterly, lump sum for program activities, etc.;

(10) A copy of an indirect cost proposal when the applicant has another source of Federal funding in addition to the Rural Development HPG program;

(11) A brief description of the accounting system to be used;

(12) The method of evaluation to be used by the applicant to determine the effectiveness of its program which encompasses the requirements for quarterly reports to Rural Development in accordance with 7 CFR 1944.683(b) and the monitoring plan for rental properties and cooperatives (when applicable) according to 7 CFR 1944.689;

(13) The source and estimated amount of other financial resources to be obtained and used by the applicant for both HPG activities and housing development and/or supporting activities;

(14) The use of program income, if any, and the tracking system used for monitoring same;

(15) The applicant's plan for disposition of any security instruments held by them as a result of its HPG activities in the event of its loss of legal status;

(16) Any other information necessary to explain the proposed HPG program; and

(17) The outreach efforts outlined in 7 CFR 1944.671(b).

(b) Complete information about the applicant's experience and capacity to carry out the objectives of the proposed HPG program.

(c) Evidence of the applicant's legal existence, including, in the case of a private non-profit organization, which may include, but not be limited to, Faith-Based and community organizations, a copy of, or an accurate reference to, the specific provisions of State law under which the applicant is organized; a certified copy of the applicant's Articles of Incorporation and Bylaws or other evidence of corporate existence; certificate of incorporation for other than public bodies; evidence of good standing from the State when the corporation has been in existence 1 year or more; and the names and addresses of the applicant's members, directors and officers. If other organizations are members of the applicant-organization, or the applicant is a consortium, pre-applications should be accompanied by the names, addresses, and principal purpose of the other organizations. If the applicant is a consortium, documentation showing compliance with paragraph (4)(ii) under the definition of “organization” in 7 CFR 1944.656 must also be included.

(d) For a private non-profit entity, which may include, but not be limited to, Faith-Based and community organizations, the most recent audited statement and a current financial statement dated and signed by an authorized officer of the entity showing the amounts and specific nature of assets and liabilities together with information on the repayment schedule and status of any debt(s) owed by the applicant.

(e) A brief narrative statement which includes information about the area to be served and the need for improved housing (including both percentage and the actual number of both low-income and low-income minority households and substandard housing), the need for the type of housing preservation assistance being proposed, the anticipated use of HPG resources for historic properties, the method of evaluation to be used by the applicant in determining the effectiveness of its efforts.

(f) A statement containing the component for alleviating any overcrowding as defined by 7 CFR 1944.656.

(g) A signed copy of the documentation in accordance with 7 CFR 1944.673 (as a companion to (a)(3) above);

(h) The applicant must submit written statements and related correspondence reflecting compliance with 7 CFR 1944.674(a) and (c) regarding consultation with local Government leaders in the preparation of its program and the consultation with local and State Government pursuant to the provisions of Executive Order 12372.

(i) The applicant is to make its statement of activities available to the public for comment prior to submission to Rural Development pursuant to 7 CFR 1944.674(b). The application must contain a description of how the comments (if any were received) were addressed.

(j) The applicant must submit an original and one copy of Form RD 400-1, “Equal Opportunity Agreement,” and Form RD 400-4, “Assurance Agreement,” in accordance with 7 CFR 1944.676.

Applicants should review 7 CFR part 1944, subpart N for a comprehensive list of all application requirements.

3. Address unique entity identifier and System for Award Management (SAM): As part of the application, all applicants, except for individuals or agencies excepted under 2 CFR 25.110(d), must be: (1) Registered in the System for Award Management (SAM); (2) provide a valid unique entity identifier in its applications; and (3) maintain an active SAM registration with current information at all times during which it has an active Federal award or application. An award may not be made to the applicant until the applicant has complied with the unique entity identifier and SAM requirements.

4. Intergovernmental Review: The HPG program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

5. Funding Restrictions: There are no limits on proposed direct and indirect costs. Expenses incurred in developing pre-applications will be at the applicant's risk.

6. Other Submission Requirements: To comply with the President's Management Agenda, USDA is participating as a partner in the Government-wide grants.gov site. Housing Preservation Grants [Catalog of Federal Domestic Assistance #10.433] is one of the programs included at this website. If you are an applicant under the HPG program, you may submit your pre-application to the Agency in either electronic or paper format. Please be mindful that the pre-application deadline for electronic format differs from the deadline for paper format. The electronic format deadline will be based on Eastern Standard Time. The paper format deadline is local time for each Rural Development State Office.

Users of Grants.gov will be able to download a copy of the pre-application package, complete it off line, and then upload and submit the application via the Grants.gov site. You may not email an electronic copy of a grant pre-application to USDA Rural Development; however, the Agency encourages your participation in Grants.gov.

The following are useful tips and instructions on how to use the website:

• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site as well as the hours of operation. USDA-Rural Development strongly recommends that you do not wait until the application deadline date to begin the application process through Grants.gov. To use Grants.gov, applicants must have a DUNS number.

• You may submit all documents electronically through the website, including all information typically included on the Application for Housing Preservation Grants, and all necessary assurances and certifications.

• After you electronically submit your application through the website, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.

• RHS may request that you provide original signatures on forms at a later date.

• If you experience technical difficulties on the closing date and are unable to meet the 5:00 p.m. (Eastern Standard Time) deadline, print out your application and submit it to your State Office, you must meet the closing date and local time deadline.

• Please note that you must locate the downloadable application package for this program by the CFDA Number or FedGrants Funding Opportunity Number, which can be found at http://www.grants.gov.

In addition to the electronic pre-application at the http://www.grants.gov website, all applicants must complete and submit the FY 2018 pre-application package, detailed later in this Notice, for the Section 533 HPG program. A copy of a suggested coversheet is included with this Notice. Applicants are encouraged to submit this pre-application coversheet electronically by accessing the website: http://www.rd.usda.gov/programs-services/housing-preservation-grants. Click on the Forms & Resources tab to access the “FY 2018 Pre-application for Section 533 Housing Preservation Grants (HPG).”

Applicants are encouraged, but not required, to also provide an electronic copy of all hard copy forms and documents submitted in the pre-application/application package as requested by this Notice. The forms and documents must be submitted as read-only Adobe Acrobat PDF files on an electronic media such as CDs, DVDs or USB drives. For each electronic device that you submit, you must include a Table of Contents listing all of the documents and forms on that device. The electronic medium must be submitted to the local Rural Development State Office where the project will be located.

Please Note: If you receive a loan or grant award under this Notice, USDA reserves the right to post all information that is not protected by the Privacy Act submitted as part of the pre-application/application package on a public website with free and open access to any member of the public.

E. Application Review Information

1. Criteria. All paper applications for Section 533 HPG funds must be filed with the appropriate Rural Development State Office and all paper or electronic applications must meet the requirements of this Notice and 7 CFR part 1944, subpart N. Pre-applications determined not eligible and/or not meeting the selection criteria will be notified by the Rural Development State Office.

2. Review and Selection Process. The Rural Development State Offices will utilize the following threshold project selection criteria for applicants in accordance with 7 CFR 1944.679:

(a) Providing a financially feasible program of housing preservation assistance. “Financially feasible” is defined as proposed assistance which will be affordable to the intended recipient or result in affordable housing for very low- and low-income persons.

(b) Serving eligible rural areas with a concentration of substandard housing for households with very low- and low-income.

(c) Being an eligible applicant as defined in 7 CFR 1944.658.

(d) Meeting the requirements of consultation and public comment in accordance with 7 CFR 1944.674.

3. Scoring. For applicants meeting all of the requirements listed above, the Rural Development State Offices will use weighted criteria in accordance with 7 CFR part 1944, subpart N as selection for the grant recipients. Each pre-application and its accompanying statement of activities will be evaluated and, based solely on the information contained in the pre-application, the applicant's proposal will be numerically rated on each criteria within the range provided. The highest-ranking applicant(s) will be selected based on allocation of funds available to the State.

(a) Points are awarded based on the percentage of very low-income persons that the applicant proposes to assist, using the following scale:

(b) The applicant's proposal may be expected to result in the following percentage of HPG fund use (excluding administrative costs) to total cost of unit preservation. This percentage reflects maximum repair or rehabilitation with the least possible HPG funds due to leveraging, innovative financial assistance, owner's contribution or other specified approaches. Points are awarded based on the following percentage of HPG funds (excluding administrative costs) to total funds:

(c) The applicant has demonstrated its administrative capacity in assisting very low- and low-income persons to obtain adequate housing based on the following:

(1) The organization or a member of its staff has at least one or more years' experience successfully managing and operating a rehabilitation or weatherization type program: 10 points.

(2) The organization or a member of its staff has at least one or more years' experience successfully managing and operating a program assisting very low- and low-income persons obtain housing assistance: 10 points.

(3) If the organization has administered grant programs, there are no outstanding or unresolved audit or investigative findings which might impair carrying out the proposal: 10 points.

(d) The proposed program will be undertaken entirely in rural areas outside Metropolitan Statistical Areas, also known as MSAs, identified by Rural Development as having populations below 10,000 or in remote parts of other rural areas (i.e., rural areas contained in MSAs with less than 5,000 population) as defined in 7 CFR 1944.656: 10 points.

(e) The program will use less than 20 percent of HPG funds for administration purposes:

(f) The proposed program contains a component for alleviating overcrowding as defined in 7 CFR 1944.656: 5 points.

In the event more than one pre-application receives the same amount of points, those pre-applications will then be ranked based on the actual percentage figure used for determining the points. Further, in the event that pre-applications are still tied, then those pre-applications still tied will be ranked based on the percentage for HPG fund use (low to high). Further, for applications where assistance to rental properties or cooperatives is proposed, those still tied will be further ranked based on the number of years the units are available for occupancy under the program (a minimum of 5 years is required). For this part, ranking will be based from most to least number of years.

Finally, if there is still a tie, then a lottery system will be used. After the award selections are made, all applicants will be notified of the status of their applications by mail.

F. Federal Award Administration Information

1. Federal Award Notices. The Agency will notify, in writing, applicants whose pre-applications have been selected for funding. At the time of notification, the Agency will advise the applicant what further information and documentation is required along with a timeline for submitting the additional information. If the Agency determines it is unable to select the application for funding, the applicant will be so informed in writing. Such notification will include the reasons the applicant was not selected. The Agency will advise applicants, whose pre-applications did not meet eligibility and/or selection criteria, of their review rights or appeal rights in accordance with 7 CFR 1944.682.

2. Administrative and National Policy Requirements. Rural Development is encouraging applications for projects that will support rural areas with persistent poverty. This emphasis will support Rural Development's mission of improving the quality of life for Rural Americans and commitment to directing resources to those who most need them.

3. Reporting. Post-award reporting requirements can be found in the Grant Agreement.

G. Non-Discrimination Statement

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees and institutions participating in or administering USDA programs are prohibited from discrimination based on race, color, national origin, religion, sex, gender identity, (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form (PDF), found online at http://www.ascr.usda.gov/complaint_filing_cust.html, and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

Applicants are encouraged; but not required, to submit this pre-application form electronically by accessing the website: http://www.rd.usda.gov/programs-services/housing-preservation-grants. Click on the Forms & Resources tab to access the “Fiscal Year 2018 Pre-Application for Section 533 Housing Preservation Grants (HPG).” Please note that electronic submittals are not on a secured website. If you do not wish to submit the form electronically by clicking on the Send Form button, you may still fill out the form, print it and submit it with your application package to the State Office. You also have the option to save the form, and submit it on an electronic media to the State Office.

Supporting documentation required by this pre-application may be attached to the email generated when you click the Send Form button to submit the form. However, if the attachments are too numerous or large in size, the email box will not be able to accept them. In that case, submit the supporting documentation for this pre-application to the State Office with your complete application package under item IX.

Documents Submitted, indicate the supporting documents that you are submitting either with the pre-application or to the State Office.

The Architectural and Transportation Barriers Compliance Board (Access Board) plans to hold its regular committee and Board meetings in Washington, DC, Monday through Wednesday, July 9-11, 2018 at the times and location listed below.

Members of the public can provide comments either in-person or over the telephone during the final 15 minutes of the Board meeting on Wednesday, July 11, 2018. Any individual interested in providing comment is asked to pre-register by sending an email to bunales@access-board.gov with the subject line “Access Board meeting—Public Comment” with your name, organization, state, and topic of comment included in the body of your email. All emails to register for public comment must be received by Tuesday, July 3. Commenters will be provided with a call-in number and passcode before the meeting. Commenters will be called on in the order by which they are pre-registered. Due to time constraints, each commenter is limited to two minutes. Commenters on the telephone will be in a listen-only capacity until they are called on.

All meetings are accessible to persons with disabilities. An assistive listening system, Communication Access Realtime Translation (CART), and sign language interpreters will be available at the Board meeting and committee meetings.

Persons attending Board meetings are requested to refrain from using perfume, cologne, and other fragrances for the comfort of other participants (see www.access-board.gov/the-board/policies/fragrance-free-environment for more information).

You may view the Wednesday, July 11, 2018 meeting through a live webcast from 1:30 p.m. to 3:00 p.m. at: www.access-board.gov/webcast.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the North Dakota Advisory Committee to the Commission will convene on Monday, July 9, 2018, at 4:00 p.m. (CDT) at the Fargo Public Central Library, Fercho Room, 102 3rd Street North, Fargo, ND 58102. The purpose of the meeting is to hold the first meeting of the committee and discuss civil rights topics.

If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at ebohor@usccr.gov at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting.

Time will be set aside at the end of the meeting so that members of the public may address the Committee after the planning meeting. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Thursday, August 9, 2018. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1040, or emailed to Evelyn Bohor at ebohor@usccr.gov. Persons who desire additional information may contact the Rocky Regional Office at (303) 866-1040.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/meetings.aspx?cid=267 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Rocky Mountain Regional Office at the above phone number, email or street address.

The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

Agency: Bureau of Industry and Security.

Title: Statement by Ultimate Consignee and Purchaser.

Form Number(s): BIS-711.

OMB Control Number: 0694-0021.

Type of Review: Regular submission.

Estimated Total Annual Burden Hours: 110.

Estimated Number of Respondents: 414.

Estimated Time per Response: 16 minutes.

Needs and Uses: The collection is necessary under Part 748.11 of the EAR. This section states that the Form BIS-711, Statement by Ultimate Consignee and Purchaser, or a statement on company letterhead (in accordance with 748.11(b)(1)), must provide information on the foreign importer receiving the U.S. technology and how the technology will be utilized. The BIS-711 or letter provides assurances from the importer that the technology will not be misused, transferred or re-exported in violation of the EAR.

Affected Public: Business or other for-profit organizations.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

This information collection request may be viewed at reginfo.govhttp://www.reginfo.gov/public/. Follow the instructions to view Department of Commerce collections currently under review by OMB.

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to OIRA_Submission@omb.eop.gov.

The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

Agency: Office of the Chief Information Officer, Office of the Secretary, Commerce.

Title: The Research Performance Progress Report.

OMB Control Number: 0690-0032.

Form Number(s): None.

Type of Request: Revision of a currently approved collection.

Estimated Number of Respondents: 2,550.

Estimated Time per Response: 5 hours.

Estimated Total Annual Burden Hours: 12,750.

Needs and Uses: The development of the Research Performance Progress Report (RPPR) resulted from an initiative of the Research Business Models (RBM), an Interagency Working Group of the Social, Behavioral & Economic Research, Subcommittee of the Committee on Science (CoS), a committee of the National Science and Technology Council (NSTC). One of the RBM Subcommittee's priority areas was to create greater consistency in the administration of Federal research awards. Given the increasing complexity of interdisciplinary and interagency research, it is important for Federal agencies to manage awards in a similar fashion. The RPPR is an OMB approved uniform format to be used by Federal agencies in submission of progress reports that support research and research-related activities. It is intended to replace other performance reporting formats currently in use by Federal agencies. However, the RPPR does not change the performance reporting requirements specified in 2 CFR 200.

Eastman Kodak Company (Eastman Kodak) submitted a notification of proposed production activity to the FTZ Board for its facility in Weatherford, Oklahoma. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on June 13, 2018.

Eastman Kodak already has authority to produce flexographic finished plates, aluminum finished printing plates, thermo imaging layer, direct imaging recording film sheets, and direct imaging record film rolls within Subzone 106F. The current request would add foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

Production under FTZ procedures could exempt Eastman Kodak from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, Eastman Kodak would be able to choose the duty rates during customs entry procedures that apply to finished products in the existing scope of authority. Eastman Kodak would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is August 6, 2018.

A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via www.trade.gov/ftz.

For further information, contact Christopher Wedderburn at Chris.Wedderburn@trade.gov or (202) 482-1963.

An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the State of Hawaii, grantee of FTZ 9, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on June 18, 2018.

The grantee's proposed service area under the ASF would be the City and County of Honolulu, County of Hawaii, County of Kauai, and County of Maui, Hawaii, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The application indicates that the proposed service area is within and adjacent to the Hilo and Kona (Hawaii), Kahului and Kihei (Maui), Honolulu (Oahu); and, Nawiliwili-Port Allen (Kauai) U.S. Customs and Border Protection ports of entry.

The applicant is requesting authority to reorganize its zone to include existing Sites 2, 3, 4, 5 and 9 as “magnet” sites and existing Sites 1, 6, 7 and 8 as usage-driven sites. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 5 be so exempted. No additional ASF subzones/usage-driven sites are being requested at this time. The application would have no impact on FTZ 9's previously authorized subzones.

In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.

Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is August 24, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to September 10, 2018.

A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's website, which is accessible via www.trade.gov/ftz. For further information, contact Christopher Kemp at Christopher.Kemp@trade.gov or (202) 482-0862.

On August 31, 2017, in the U.S. District Court for the Southern District of New York, Fuyi Sun, a/k/a Frank Sun (“Sun”), was convicted of violating the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2012)) (“IEEPA”). Specifically, Sun knowingly and willfully attempted to export and cause to be exported from the United States to China Toray type M60JB-3000-50B carbon fiber, without the required U.S. Department of Commerce licenses. Sun was sentenced to 36 months in prison, with credit for time served and a $100 assessment.

Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”) 1 provides, in pertinent part, that “[t]he Director of the Office of Exporter Services, in consultation with the Director of the Office of Export Enforcement, may deny the export privileges of any person who has been convicted of a violation of the EAA [Export Administration Act], the EAR, or any order, license or authorization issued thereunder; any regulation, license, or order issued under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706); 18 U.S.C. 793, 794 or 798; section 4(b) of the Internal Security Act of 1950 (50 U.S.C. 783(b)), or section 38 of the Arms Export Control Act (22 U.S.C. 2778).” 15 CFR 766.25(a); see also Section 11(h) of the Export Administration Act (“EAA” or “the Act”), 50 U.S.C. 4610(h). The denial of export privileges under this provision may be for a period of up to 10 years from the date of the conviction. 15 CFR 766.25(d); see also 50 U.S.C. 4610(h). In addition, Section 750.8 of the Regulations states that the Bureau of Industry and Security's Office of Exporter Services may revoke any Bureau of Industry and Security (“BIS”) licenses previously issued pursuant to the Act or Regulations, in which the person had an interest in at the time of his/her conviction.

1 The Regulations are currently codified in the Code of Federal Regulations at 15 CFR parts 730-774 (2017). The Regulations issued pursuant to the Export Administration Act (50 U.S.C. 4601-4623 (Supp. III 2015) (available at http://uscode.house.gov)) (“EAA” or “the Act”). Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), which has been extended by successive Presidential Notices, the most recent being that of August 15, 2017 (82 FR 39005 (Aug. 16, 2017)), has continued the Regulations in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701, et seq. (2012)).

BIS has received notice of Sun's conviction for violating the IEEPA, and has provided notice and an opportunity for Sun to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Sun.

Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Sun's export privileges under the Regulations for a period of 10 years from the date of Sun's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Sun had an interest at the time of his conviction.

Accordingly, it is hereby ordered:

First, from the date of this Order until August 31, 2027, Fuyi Sun, a/k/a Frank Sun, with a last known address of Inmate Number—77362-054, Moshannon Valley Correctional Institution, 555 Geo Drive, Philipsburg, PA 16866, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (“the Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:

A. Applying for, obtaining, or using any license, license exception, or export control document;

B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or

C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.

Second, no person may, directly or indirectly, do any of the following:

A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;

B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;

C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;

D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Sun by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.

Fourth, in accordance with Part 756 of the Regulations, Sun may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

Fifth, a copy of this Order shall be delivered to the Sun, and shall be published in the Federal Register.

Sixth, this Order is effective immediately and shall remain in effect until August 31, 2027.

Enforcement and Compliance, International Trade Administration, Department of Commerce.

Background: On June 1, 2018, the Department of Commerce (Commerce) published the July 2018 Advance Sunset Review Notice,1 in which Commerce inadvertently listed the initiation of Lemon Juice from Argentina (A-357-818) for July 2018. The sunset review of Lemon Juice from Argentina is not scheduled to be initiated in July 2018; the error was based on a former suspension agreement, which was superseded by a new agreement on October 26, 2016.2 This notice serves to correct the July 2018 Advance Sunset Review Notice. There will be no sunset reviews initiated in July 2018, because Lemon Juice from Argentina was the only case for which a sunset review was scheduled.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Notice of a public meeting.

SUMMARY:

The Caribbean Fishery Management Council's (Council) Scientific and Statistical Committee (SSC) will hold a 3-day meeting in July to discuss the items contained in the agenda in the SUPPLEMENTARY INFORMATION.

DATES:

The meetings will be held from Tuesday, July 17, 2018, at 9 a.m., through Thursday, July 19, 2018, at 5 p.m.

ADDRESSES:

The meetings will be held at the Courtyard Marriott Isla Verde Resort, 7012 Boca de Cangrejos, Avenida Isla Verde, Carolina, Puerto Rico 00979.

SUPPLEMENTARY INFORMATION:—Call to Order—Adoption of Agenda—Overview1. Review outcomes from the May 29, 2018 SSC meeting2. Review and finalize U.S. Virgin Islands year sequence3. Review text of Acceptable Biological Catch Control Rule4. Address outstanding issues for Actions 2 and 3 in the Island Based Fishery Management Plans, including:a. Clarify rationale for certain recommended species groupings under Action 2b. Revisit terminal year for Puerto Rico commercial species new to managementc. Other issues—Recommendations to the Caribbean Fishery Management Council for research priorities—Other Business

The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meeting will begin on July 17, 2018 at 9 a.m. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated. In addition, the meeting may be extended from, or completed prior to the date established in this notice

The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Type of Request: Regular (extension of a currently approved information collection).

Number of Respondents: 250.

Average Hours per Response: 7 minutes.

Burden Hours: 29.

Needs and Uses: This request is for extension of a currently approved information collection. Mokupapapa Discovery Center (Center) is an outreach arm of Papahanaumokuakea Marine National Monument that reaches 65,000 people each year in Hilo, Hawai`i. The Center was opened fifteen years ago to help raise support for the creation of a National Marine Sanctuary in the Northwestern Hawaiian Islands. Since that time, the area has been proclaimed a Marine National Monument and the main messages we are trying to share with the public have changed to better reflect the new monument status, UNESCO World Heritage status and the joint management by the three co-trustees of the Monument. We therefore are seeking to find out if people visiting our Center are receiving our new messages by conducting an optional exit survey.

Affected Public: Individuals or households.

Frequency: One time.

Respondent's Obligation: Voluntary.

This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to OIRA_Submission@omb.eop.gov or fax to (202) 395-5806.

The Summer Flounder, Scup, and Black Sea Bass Monitoring Committee will meet to recommend 2019 commercial and recreational Annual Catch Limits (ACLs) and Annual Catch Targets (ACTs) for summer flounder and black sea bass, as well as review the previously implemented 2019 ACLs and ACTs for scup. The Monitoring Committee will consider the results of a collaborative research mesh size study, and review and recommend changes, if needed, to commercial management measures for all three species. Other agenda items include a review of the 2018 black sea bass February recreational fishery, an update on a Management Strategy Evaluation (MSE) for recreational summer flounder management, a discussion of the ongoing Recreational Issues Framework Action/Addendum for all three species, and a preliminary discussion of revised recreational catch estimates from the Marine Recreational Information Program (MRIP). Meeting materials will be posted to http://www.mafmc.org/ prior to the meeting.

Special Accommodations

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders at the Mid-Atlantic Council Office, (302) 526-5251, at least 5 days prior to the meeting date.

The purpose of this meeting is to make multi-year acceptable biological catch (ABC) recommendations for Chub Mackerel based on the most recent and appropriate information available. The SSC will also make ABC recommendations for the 2019 fishing year for summer flounder and bluefish based on the most recent fishery information. A review the most recent survey and fishery data and the currently implemented 2019 ABC for scup and the previously recommended 2019 ABC for black sea bass will also be conducted. In addition, the SSC may take up any other business as necessary.

A detailed agenda and background documents will be made available on the Council's website (www.mafmc.org) prior to the meeting.

Special Accommodations

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

The South Atlantic Fishery Management Council (Council) will hold meetings of the following Citizen Science Advisory Panel Action Teams: Projects/Topics Management; Data Management; Volunteers; and Communication/Outreach/Education. The meetings will be held via webinar.

DATES:

The Projects/Topics Management Team meeting will be held on Tuesday, July 10, 2018 at 11 a.m.; Data Management Team on Thursday, July 12, 2018 at 10 a.m.; Volunteers Team on July 12, 2018 at 2 p.m.; and Communication/Outreach/Education Team on Friday, July 13, 2018 at 10 a.m. Each meeting is scheduled to last approximately 90 minutes. Additional Action Team webinar and plenary webinar dates and times will publish in a subsequent issue in the Federal Register.

ADDRESSES:

Meeting address: The meetings will be held via webinar and are open to members of the public. Webinar registration is required and registration links will be posted to the Citizen Science program page of the Council's website at www.safmc.net.

The Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of Volunteers, Data Management, Projects/Topics Management, Finance, and Communication/Outreach/Education to develop program policies and operations for the Council's Citizen Science Program.

Each Action Team will meet to continue work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee. Public comment will be accepted at the beginning of the meeting. Items to be addressed during these meetings:

1. Discuss work on tasks in the Terms of Reference2. Other BusinessSpecial Accommodations

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see ADDRESSES) 5 days prior to the meeting.

Note: The times and sequence specified in this agenda are subject to change.

The Commodity Futures Trading Commission (“CFTC” or “Commission”) charges fees to designated contract markets and registered futures associations to recover the costs incurred by the Commission in the operation of its program of oversight of self-regulatory organization rule enforcement programs, specifically National Futures Association (“NFA”), a registered futures association, and the designated contract markets. Fees collected from each self-regulatory organization are deposited in the Treasury of the United States as miscellaneous receipts. The calculation of the fee amounts charged for 2017 by this notice is based upon an average of actual program costs incurred during fiscal year (“FY”) 2014, FY 2015, and FY 2016.

DATES:

Each self-regulatory organization is required to remit electronically the applicable fee on or before August 24, 2018.

This notice relates to fees for the Commission's review of the rule enforcement programs at the registered futures associations 1 and designated contract markets (“DCM”), each of which is a self-regulatory organization (“SRO”) regulated by the Commission. The Commission recalculates the fees charged each year to cover the costs of operating this Commission program.2 The fees are set each year based on direct program costs, plus an overhead factor. The Commission calculates actual costs, then calculates an alternate fee taking volume into account, and then charges the lower of the two.3

1 National Futures Association is the only registered futures association.

2See Section 237 of the Futures Trading Act of 1982, 7 U.S.C. 16a, and 31 U.S.C. 9701. For a broader discussion of the history of Commission fees, see 52 FR 46070, Dec. 4, 1987.

3 58 FR 42643, Aug. 11, 1993, and 17 CFR part 1, appendix B.

B. Overhead Rate

The fees charged by the Commission to the SROs are designed to recover program costs, including direct labor costs and overhead. The overhead rate is calculated by dividing total Commission-wide overhead direct program labor costs into the total amount of the Commission-wide overhead pool. For this purpose, direct program labor costs are the salary costs of personnel working in all Commission programs. Overhead costs generally consist of the following Commission-wide costs: Indirect personnel costs (leave and benefits), rent, communications, contract services, utilities, equipment, and supplies. This formula has resulted in the following overhead rates for the most recent three years (rounded to the nearest whole percent): 180 percent for FY 2014, 211 percent for FY 2015, and 190 percent for FY 2016.

C. Conduct of SRO Rule Enforcement Reviews

Under the formula adopted by the Commission in 1993, the Commission calculates the fee to recover the costs of its rule enforcement reviews and examinations, based on the three-year average of the actual cost of performing such reviews and examinations at each SRO. The cost of operation of the Commission's SRO oversight program varies from SRO to SRO, according to the size and complexity of each SRO's program. The three-year averaging computation method is intended to smooth out year-to-year variations in cost. Timing of the Commission's reviews and examinations may affect costs—a review or examination may span two fiscal years and reviews and examinations are not conducted at each SRO each year.

As noted above, adjustments to actual costs may be made to relieve the burden on an SRO with a disproportionately large share of program costs. The Commission's formula provides for a reduction in the assessed fee if an SRO has a smaller percentage of United States industry contract volume than its percentage of overall Commission oversight program costs. This adjustment reduces the costs so that, as a percentage of total Commission SRO oversight program costs, they are in line with the pro rata percentage for that SRO of United States industry-wide contract volume.

The calculation is made as follows: The fee required to be paid to the Commission by each DCM is equal to the lesser of actual costs based on the three-year historical average of costs for that DCM or one-half of average costs incurred by the Commission for each DCM for the most recent three years, plus a pro rata share (based on average trading volume for the most recent three years) of the aggregate of average annual costs of all DCMs for the most recent three years.

The formula for calculating the second factor is: 0.5a + 0.5 vt = current fee. In this formula, “a” equals the average annual costs, “v” equals the percentage of total volume across DCMs over the last three years, and “t” equals the average annual costs for all DCMs. NFA has no contracts traded; hence, its fee is based simply on costs for the most recent three fiscal years. The following table summarizes the data used in the calculations of the resulting fee for each entity:

Table 1—Summary of Data Used in Fee CalculationsActual total costsFY 2014FY 2015FY 20163-Year

average

actual costs

3-Year

average

volume

(%)

Adjusted

volume

costs

2016

Actual

fee

2017

Assessed

fee

CBOE Futures$158,209$227,059$128,4231.31$71,004$73,074$71,004Chicago Board of Trade$55,51517,93828,72034,05829.61170,55479,47634,058Chicago Mercantile Exchange225,701540,151372,278379,37744.66421,246385,923379,377ICE Futures U.S81,176105,864386,719191,2539.22143,431153,429143,431Minneapolis Grain Exchange47,648147,98314,31469,9810.0535,25069,74135,250NADEX North American98081,75827,5790.1414,51617,50514,516New York Mercantile Exchange225,672118,701242,792195,72214.49172,990159,897172,990One Chicago31,19628928210,5890.296,79828,3846,798NASDAQ0.211,089ERIS Exchange0.0168NY LIFFE4,909ELX Futures22,378KCBT186Subtotal667,8881,089,1341,353,921$1,036,9811001,036,945994,901857,423National Futures Association292,102401,337282,405325,281293,312325,281Total959,9901,490,4711,636,3261,362,262$1,288,2141,182,704Note to Table 1: The 2017 Fee is the lesser of the 3-Year Average Actual Cost or the Adjusted Volume Cost. NY LIFFE, ELX, and KCBT are either Vacated or Dormant, but had direct labor costs in 2013 that produced a fee in 2016, based on the 3-Year Average.

An example of how the fee is calculated for one exchange, the Chicago Board of Trade, is set forth here:

As noted above, the alternative calculation based on contracts traded is not applicable to NFA because it is not a DCM and has no contracts traded. The Commission's average annual cost for conducting oversight review of the NFA rule enforcement program during fiscal years 2014 through 2016 was $325,281. The fee to be paid by the NFA for the current fiscal year is $325,281.

II. Schedule of Fees

Fees for the Commission's review of the rule enforcement programs at the registered futures associations and DCMs regulated by the Commission are as shown in the following table:

The Debt Collection Improvement Act (“DCIA”) requires deposits of fees owed to the government by electronic transfer of funds. See 31 U.S.C. 3720. For information about electronic payments, please contact Jennifer Fleming at (202) 418-5034 or jfleming@cftc.gov, or see the CFTC website at www.cftc.gov, specifically, www.cftc.gov/cftc/cftcelectronicpayments.htm.

Fees collected from each self-regulatory organization shall be deposited in the Treasury of the United States as miscellaneous receipts. See 7 U.S.C. 16a.

The Commodity Futures Trading Commission (CFTC or Commission) is announcing an opportunity for public comment on the proposed extension of the collection of certain information by the agency. Under the Paperwork Reduction Act (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection, and to allow 60 days for public comment. This notice solicits comments on the collection of information provided for by the Commission's regulations governing bankruptcies of commodity brokers.

DATES:

Comments must be submitted on or before August 24, 2018.

ADDRESSES:

You may submit comments, identified by OMB Control No. 3038-0021, by any of the following methods:

• CFTC Comments Portal:https://comments.cftc.gov. Select the “Submit Comments” link for this matter and follow the instructions on the Public Comment Form.

• Hand Delivery/Courier: Follow the same instructions as for Mail, above.

Please submit your comments using only one of these methods. To avoid possible delays with mail or in-person deliveries, submissions through the CFTC Comments Portal are encouraged. All comments must be submitted in English or, if not, accompanied by an English translation. Comments will be posted as received to https://comments.cftc.gov.

Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed extension of the collection of information listed below.

Title: Regulations Governing Bankruptcies of Commodity Brokers (OMB Control No. 3038-0021). This is a request for an extension of a currently approved information collection.1

1 There are two information collections now associated with OMB Control No. 3038-0021. The first includes the reporting, recordkeeping, and third party disclosure requirements applicable to a single respondent in a commodity broker liquidation (e.g., a single commodity broker or a single trustee) within the relevant time period provided for in Commission regulations 190.02(a)(1), 190.02(a)(2), 190.02(b)(1), 190.02(b)(2), 190.02(b)(4), 190.02(c), 190.03(a)(1), 190.03(a)(2), 190.04(b) and 190.06(b). The second information collection includes third party disclosure requirements that are applicable on a regular basis to multiple respondents (i.e., multiple futures commission merchants) provided for in Commission regulations 190.06(d) and 190.10(c).

Abstract: This collection of information involves the reporting, recordkeeping, and third party disclosure requirements set forth in the CFTC's bankruptcy regulations for commodity broker liquidations, 17 CFR part 190.2 These regulations apply to commodity broker liquidations under Chapter 7, Subchapter IV of the Bankruptcy Code.3

The reporting requirements include, for example, notices to the Commission regarding the filing of petitions for bankruptcy and notices to the Commission regarding the intention to transfer open commodity contracts in a commodity broker liquidation. The recordkeeping requirements include, for example, the statements of customer accounts that a trustee appointed for the purposes of a commodity broker liquidation (Trustee) must generate and adjust as set forth in the regulations. The third party disclosure requirements include, for example, the disclosure statement that a commodity broker must provide to its customers containing information regarding the manner in which customer property is treated under part 190 of the Commission's regulations in the event of a bankruptcy and, in the event of a commodity broker liquidation, certain notices that a Trustee must provide to customers and to the persons to whom commodity contracts and specifically identifiable customer property have been or will be transferred. The information collection requirements are necessary, and will be used, to facilitate the effective, efficient, and fair conduct of liquidation proceedings for commodity brokers and to protect the interests of customers in these proceedings both directly and by facilitating the participation of the CFTC in such proceedings.

With respect to the collections of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

• Ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses.

You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act (FOIA), a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.4 The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from https://comments.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the information collection requirements will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the FOIA.

4 17 CFR 145.9.

Burden Statement: The Commission notes that commodity broker liquidations occur at unpredictable and irregular intervals when particular commodity brokers become insolvent. While a commodity broker liquidation has not occurred in the past three years, the Commission took the conservative approach of maintaining the assumption contained in the previous renewal of this information collection that, on average, a commodity broker liquidation would occur every three years. The Commission generally has retained the burden hour estimates set forth in the previous information collection as there have been no interim experiences nor are there currently apparent circumstances that would warrant altering those estimates.5 The Commission further notes, however, that the information collection burden will vary in particular commodity broker liquidations depending on the size of the commodity broker, the extent to which accounts are able to be quickly transferred, and other factors specific to the circumstances of the liquidation.

5 The Commission has retained the burden hour estimates for each of the applicable regulations except that the Commission no longer assigns burden hours to the discretionary notice that a Trustee may provide to customers in an involuntary commodity broker liquidation pursuant to Commission regulation 190.02(b)(3). There have been no involuntary commodity broker liquidations and none are anticipated. Accordingly, continuing to assign burden hours to this voluntary requirement would inappropriately inflate the burden hours of this information collection.

The respondent burden for this information collection is estimated to be as follows: 6

6 Because a commodity broker liquidation is estimated to occur only once every three years, the previous information collection expressed the burden of the reporting, recordkeeping, and third party disclosure requirements in terms of the burden applicable to “.33” respondents in many cases. For clarity, this notice expresses such burdens in terms of those that would be imposed on one respondent during the three year period. While the applicable burden is expressed in a different way, as noted above, the burden hours generally remain unchanged.

Reporting:7

7 The reporting requirements are contained in Commission regulations 190.02(a)(1), 190.02(a)(2), and 190.06(b).

8 The recordkeeping requirements are contained in Commission regulations 190.03(a)(1), 190.03(a)(2), and 190.04(b).

Estimated Number of Respondents: 1.

Estimated Annual Number of Responses per Respondent: 26,666.67.

Estimated Total Annual Number of Responses: 26,666.67.

Estimated Annual Number of Burden Hours per Respondent: 333.33.

Estimated Total Annual Burden Hours: 333.33.

Type of Respondents: Trustees.

Frequency of Collection: Daily and on occasion.

Third Party Disclosures Applicable to a Single Respondent:9

9 These third party disclosure requirements are contained in Commission regulations 190.02(b)(1), 190.02(b)(2), 190.02(b)(4), and 190.02(c).

Estimated Number of Respondents: 1.

Estimated Annual Number of Responses per Respondent: 6,671.32.

Estimated Total Annual Number of Responses: 6,671.32.

Estimated Annual Number of Burden Hours per Respondent: 1,034.63.

Estimated Total Annual Burden Hours: 1,034.63.

Type of Respondents: Trustees.

Frequency of Collection: On occasion.

Third Party Disclosures Applicable to a Multiple Respondents:10

10See fn. 1. The Commission is setting forth a new information collection under OMB Control No. 3038-0021 to separately account for third party disclosure requirements provided for in Commission regulations 190.06(d) and 190.06(c) that are applicable on a regular basis to multiple respondents (i.e., multiple futures commission merchants).

Estimated Number of Respondents: 125.

Estimated Annual Number of Responses per Respondent: 2,000.

Estimated Total Annual Number of Responses: 250,000.

Estimated Annual Number of Burden Hours per Respondent: 100.

Estimated Total Annual Burden Hours: 12,500.

Type of Respondents: Futures commission merchants.

Frequency of Collection: On occasion.

There are no new capital or start-up or operations costs associated with this information collection, nor are there any maintenance costs associated with this information collection.

This committee's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The charter and contact information for the Designated Federal Officer (DFO) can be obtained at http://www.facadatabase.gov/. The Board provides independent advice on matters on DoD management, business processes, and governance from a private sector perspective. The Board shall be composed of no more than 25 members who must possess the following: (a) A proven track record of sound judgment and business acumen in leading or governing large, complex private sector corporations or organizations and (b) a wealth of top-level, global business experience in the areas of executive management, corporate governance, audit and finance, human resources, economics, technology, or healthcare. Members of the Board who are not full-time or permanent part-time Federal officers or employees will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee members. Members of the Board who are full-time or permanent part-time Federal officers or employees will be appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee members. Each Board member is appointed to provide advice on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Board-related travel and per diem, Board members serve without compensation. The DoD, as necessary and consistent with the Board's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Board, and all subcommittees must operate under the provisions of FACA and the Government in the Sunshine Act. Subcommittees will not work independently of the Board and must report all recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Board. No subcommittee or any of its members can update or report, verbally or in writing, directly to the DoD or any Federal officers or employees. The Board's DFO, pursuant to DoD policy, must be a full-time or permanent part-time DoD employee, and must be in attendance for the duration of each and every Board/subcommittee meeting. The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Such statements may be submitted at any time or in response to the stated agenda of planned Board meetings. All written statements must be submitted to the Board's DFO who will ensure the written statements are provided to the membership for their consideration.

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during May 2018, it issued orders granting or vacating authority to import and export natural gas, to import and export liquefied natural gas (LNG), and to import and export compressed natural gas (CNG). These orders are summarized in the attached appendix and may be found on the FE web site at https://www.energy.gov/fe/listing-doefe-authorizationsorders-issued-2018-0.

They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation and International Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

Take notice that on June 8, 2018, Rover Pipeline LLC (Rover), 1300 Main Street, Houston, Texas 77002, filed in Docket No. CP18-500-000 an application pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations for authorization to operate a new receipt point consisting of an existing side tap on Rover's Burgettstown Lateral in Washington County, Pennsylvania (Revolution Receipt Point Project). Rover states that there are no associated construction activities or costs for the Revolution Receipt Point Project because its side tap was installed during the construction of the Burgettstown Lateral. The Revolution Receipt Point will receive up to 525,000 dekatherms per day from ETC Northeast Pipeline LLC, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at FERCOnlineSupport@ferc.gov or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

Any questions regarding this application should be directed to Blair Lichtenwalter, Senior Director, Regulatory Affairs, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002 at (713) 989-2605 or by email at Blair.Lictenwalter@energytransfer.com.

Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street NE, Washington, DC 20426.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

On June 8, 2018, Rover Pipeline LLC (Rover), 1300 Main Street, Houston, Texas 77002, filed an application pursuant to section 7(c) of the Natural Gas Act (NGA), in Docket No. CP18-499-000, for authorization to construct and operate a new meter station on Rover's Majorsville Lateral in Marshall County, West Virginia (Iron Bank Meter Station Project). Rover states that the project will consist of an ultrasonic meter skid and other ancillary facilities. Rover asserts that the Iron Bank Meter Station will receive up to 500,000 dekatherms per day of natural gas from an interconnect with the gathering facilities of APP Midstream, LLC (APP). Rover estimates the cost of the project to be $6,781,644, all to be reimbursed by APP, all as more fully set forth in the request which is on file with the Commission and open to public inspection. The filing may be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at FERCOnlineSupport@ferc.gov or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.

Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 7 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.

In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed an application submitted by the Town of Canton, Connecticut (applicant), for the reinstatement, amendment, and transfer of license for the Upper Collinsville Project No. 10822. The project is on the Farmington River near the village of Collinsville, Hartford County, Connecticut. The project does not occupy federal lands.

An environmental assessment (EA) has been prepared as part of staff's review of the proposal. In the application, the applicant proposes to rehabilitate the project, install a Kaplan turbine with a total installed capacity of 1,000 kilowatts, provide upstream and downstream fish and eel passage, and provide additional environmental measures, including water quality monitoring, mussel relocation, and recreation. The applicant requests the Commission to reinstate the license with a new term of 40-50 years. The EA contains Commission staff's analysis of the probable environmental impacts of the proposed action and concludes that approval of the proposal would not constitute a major federal action significantly affecting the quality of the human environment.

The EA is available for review and reproduction at the Commission's Public Reference Room, located at 888 First Street NE, Room 2A, Washington, DC 20426. The EA may also be viewed on the Commission's website at http://www.ferc.gov using the “elibrary” link. Enter the docket number (P-10822) in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport @ferc.gov or toll-free at 1-866-208-3372, or for TTY, (202) 502-865.

You may register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

Any comments should be filed within 30 days from the issuance date of this notice. All documents may be filed electronically via the internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's website at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be filed electronically, documents may be paper-filed. Paper filings should be mailed to: The Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. The first page of any filing should include docket number P-10822-013. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments.

The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

The Environmental Protection Agency (EPA) has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Correction of Misreported Chemical Substances on the TSCA Inventory”. This is a request to renew the approval of an existing ICR, which is currently approved through June 30, 2018. EPA did not receive any public comments in response to the previously provided public review opportunity issued in the Federal Register of February 6, 2018. With this submission to OMB, EPA is providing an additional 30 days for public review and comment.

EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR status: This ICR (EPA ICR Number 1741.08, OMB Control Number 2070-0145) is currently scheduled to expire on June 30, 2018. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Under PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable.

Abstract: This ICR pertains to the form that the chemical industry uses exclusively in submitting requests to EPA's Office of Pollution Prevention and Toxics (OPPT) for correcting misreported chemical identities of substances listed on the Inventory. Such requests pertain only to errors discovered in the original submissions to the Inventory when established in 1979.

Section 8(b) of the Toxic Substances Control Act (TSCA) requires EPA to compile and keep current an Inventory of Chemical Substances in Commerce, which is a listing of chemical substances manufactured, imported, and processed for commercial purposes in the United States. The purpose of the Inventory is to define, for the purpose of TSCA, what chemical substances exist in U.S. commerce. Since the Inventory thereby performs a regulatory function by distinguishing between existing chemicals and new chemicals, it is imperative that the Inventory be accurate. However, from time to time, EPA or respondents discover that substances have been incorrectly described by reporting companies. Reported substances have been unintentionally misidentified as a result of simple typographical errors, the misidentification of substances, or the lack of sufficient technical or analytical information to characterize fully the exact chemical substances. EPA has developed guidelines (45 FR 50544, July 29, 1980) under which incorrectly described substances listed in the Inventory can be corrected. The correction mechanism ensures the accuracy of the Inventory without imposing an unreasonable burden on the chemical industry. Without the Inventory correction mechanism, a company that submitted incorrect information would have to file a pre-manufacture notification (PMN) under TSCA section 5 to place the correct chemical substance on the Inventory whenever the previously reported substance is found to be misidentified. This would impose a much greater burden on both EPA and the submitter than the existing correction mechanism. This information collection applies to reporting and recordkeeping activities associated with the correction of misreported chemical substances found on the TSCA Inventory.

Respondents may claim all or part of a response confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

Respondents/affected entities: Manufacturers or importers of chemical substances, mixtures or categories listed on the TSCA Inventory and regulated under TSCA section 8, who had reported to EPA during the initial effort to establish the TSCA Inventory in 1979, and who need to make a correction to that submission.

Changes in the estimates: There is increase of 19 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase reflects program changes in CBI substantiation requirements, as enacted in the Frank R Lautenberg Chemical Safety Act for the 21st Century, which amended TSCA in 2016. This change is the result of a program change.

Correction and Approval of Minutes for May 24, 2018Correction and Approval of Minutes for June 7, 2018Draft Advisory Opinion 2018-09: ClementsDisposition of Open 2014 AuditsManagement and Administrative MattersCONTACT PERSON FOR MORE INFORMATION:

Judith Ingram, Press Officer, Telephone: (202) 694-1220.

Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreement are available through the Commission's website (www.fmc.gov) or by contacting the Office of Agreements at (202) 523-5793 or tradeanalysis@fmc.gov.

Agreement No.: 201262.

Title: Southern States Chassis Pool Agreement.

Parties: Georgia Ports Authority and South Carolina Ports Authority.

Filing Party: Paul Heylman; Saul Ewing Arnstein & Lehr.

Synopsis: The Agreement authorizes the parties to establish a chassis pool to service the member ports.

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 16, 2018.

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Coal Workers' Health Surveillance Program (CWHSP) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on April 12, 2018 to obtain comments from the public and affected agencies. CDC received three comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

NIOSH would like to submit an Information Collection Request (ICR) to extend the data collection instruments being utilized within the Coal Workers' Health Surveillance Program (CWHSP). This request incorporates all components of the CWHSP. Those components include: Coal Workers' X-ray Surveillance Program (CWXSP), B Reader Program, Enhanced Coal Workers' Health Surveillance Program (ECWHSP), Expanded Coal Workers' Health Surveillance Program, and National Coal Workers' Autopsy Study (NCWAS). The CWHSP is a congressionally-mandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act). The Act provides the regulatory authority for the administration of the CWHSP. This Program, which operates in accordance with 42 CFR part 37, is useful in providing information for protecting the health of and also in documenting trends and patterns in the prevalence of coal workers' pneumoconiosis (`black lung' disease) among miners employed in U.S. coal mines. The total estimated annualized burden hours of 20,281 is based on the following collection instruments:

• Coal Mine Operator Plan (2.10) and Coal Contractor Plan (2.18)—Under 42 CFR part 37, every coal operator and coal contractor in the U.S. must submit a plan approximately every 4 years, providing information on how they plan to notify their miners of the opportunity to obtain the medical examination. Completion of this form with all requested information (including a roster of current employees) takes approximately 30 minutes.

• Radiographic Facility Certification Document (2.11)—X-ray facilities seeking NIOSH approval to provide miner radiographs under the CWHSP must complete an approval packet including this form which requires approximately 30 minutes for completion.

• Miner Identification Document (2.9)—Miners who elect to participate in the CWHSP must fill out this document which requires approximately 20 minutes. This document records demographic and occupational history, as well as information required under the regulations in relation to the examinations.

• Chest Radiograph Classification Form (2.8)—NIOSH utilizes a radiographic classification system developed by the International Labour Office (ILO) in the determination of pneumoconiosis among coal miners. Physicians (B Readers) fill out this form regarding their interpretations of the radiographs (each image has at least two separate interpretations, and approximately 7% of the images require additional interpretations). Based on prior practice it takes the physician approximately 3 minutes per form.

• Physician Application for Certification (2.12)—Physicians taking the B Reader examination are asked to complete this registration form which provides demographic information as well as information regarding their medical practices. It typically takes the physician about 10 minutes to complete this form.

• Guidelines for Spirometry in the ECWHSP Mobile (Internal use, no form number assigned)—Miners (both active and former) participating in the ECWHSP component of the Program are offered a spirometry test. This form is administered by a NIOSH employee (or contractor) in the ECWHSP Mobile Unit during the initial intake process and takes approximately 5 minutes to complete. This information is required to make sure that the spirometry test can be done safely and that the miner is physically capable of performing the spirometry maneuvers.

• Spirometry Facility Certification Document (2.14)—This form is analogous to the Radiographic Facility Certification Document (2.11) and records the spirometry facility equipment/staffing information. Spirometry facilities seeking NIOSH approval to provide miner spirometry testing under the CWHSP must complete an approval packet which includes this form. It is estimated that it will take approximately 30 minutes for this form to be completed at the facility.

• Respiratory Assessment Form (2.13)—This form is designed to assess respiratory symptoms and certain medical conditions and risk factors. It is estimated that it will take approximately 5 minutes for this form to be administered to the miner by an employee at the facility.

• Spirometry Results Notification Form (2.15)—This form is used to: Collect information that will allow NIOSH to identify the miner in order to provide notification of the spirometry test results; assure that the test can be done safely; record certain factors that can affect test results; provide documentation that the required components of the spirometry examination have been transmitted to NIOSH for processing; and conduct quality assurance audits and interpretation of results. It is estimated that it will take the facility approximately 20 minutes to complete this form.

• Pathologist Invoice—Under the NCWAS, the invoice submitted by the pathologist must contain a statement that the pathologist is not receiving any other compensation for the autopsy. Each participating pathologist may use their individual invoice as long as this statement is added. It is estimated that only 5 minutes is required for the pathologist to add this statement to the standard invoice that they routinely use.

• Pathologist Report—Under the NCWAS the pathologist must submit information found at autopsy, slides, blocks of tissue, and a final diagnosis indicating presence or absence of pneumoconiosis. The format of the autopsy reports is variable depending on the pathologist conducting the autopsy. Since an autopsy report is routinely completed by a pathologist, the only additional burden is the specific request for a clinical abstract of terminal illness and final diagnosis relating to pneumoconiosis. Therefore, only 5 minutes of additional burden is estimated for the pathologist's report.

• Consent, Release and History Form (2.6)—This form documents written authorization from the next-of-kin to perform an autopsy on the deceased miner. A minimum of essential information is collected regarding the deceased miner including an occupational history and a smoking history. From past experience, it is estimated that 15 minutes is required for the next-of-kin to complete this form.

The total estimated burden hours is 20,281. There are no costs to respondents other than their time.

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March, 2018 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery—Revision—Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH).

Background and Brief Description

Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that our programs are effective and meet our customers' needs, Centers for Disease Control and Prevention (CDC's) National Institute for Occupational Safety and Health (NIOSH) seeks to obtain OMB approval of a generic clearance to collect qualitative feedback on our service delivery on collections. The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

The Agency received no comments in response to the 60-day notice published in the Federal Register on March 23, 2018 (vol. 83, No. 57, pages 12766-12768).

This is a Revision information collection request. The burden hours have decreased from the previous submission by 6,250 hours. This decrease accounts for the hours that were unused as well as the planned efforts within the Institute during the next three years. NIOSH is also planning on discontinuing 0920-0940 (expiration 3/31/2018) which accounts for service delivery data collections within NIOSH's Health Hazard Evaluation program. The current submission will account for all service delivery data collections within NIOSH.

During the past three years the information has been used by programs within NIOSH to collect feedback from customers and stakeholders. Respondents will be screened and selected from Individuals and Households, Businesses, Organizations, and/or State, Local or Tribal Government. Below we provide NIOSH's projected annualized estimate for the next three years. There is no cost to respondents other than their time. The estimated annualized burden hours for this data collection activity are 13,075.

Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), HHS.

ACTION:

Notice of proposed priorities; request for comments.

SUMMARY:

The Children's Bureau (CB) within the Administration on Children, Youth and Families (ACYF) announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect, and solicits comments regarding the prioritization.

DATES:

In order to be considered, comments must be received no later than August 24, 2018.

ADDRESSES:

You may send comments, identified by the RIN or dockets number in the subject line, by email: CBComments@acf.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

Dori Sneddon, 202-205-8024, Dori.Sneddon@acf.hhs.gov.

SUPPLEMENTARY INFORMATION:

Section 104(a)(4) of the Child Abuse Prevention and Treatment Act (CAPTA), as amended by the CAPTA Reauthorization Act of 2010, Public Law (Pub. L.) 111-320, requires the Secretary of the Department of Health and Human Services (HHS) to establish proposed priorities for research activities, provide an opportunity for public comment on those proposed activities, and maintain an official record of received public comment concerning the priorities. The proposed priorities are being announced for the 2-year period required by CAPTA. Because the amount of federal funds available for discretionary activities in fiscal years (FY) 2018-2020 is expected to be limited, respondents are encouraged to recommend how the proposed issues should be prioritized.

The actual solicitation of grant applications will be posted electronically each fiscal year and will be available online through http://www.Grants.gov. Solicitations for contracts will be announced at later dates, online at FedBizOps. No proposals, concept papers, or other forms of application should be submitted at this time.

No acknowledgement will be made of the comments submitted in response to this notice, but all comments received by the deadline will be reviewed and given thoughtful consideration in the preparation of the final funding priorities for the announcements.

I. Background

As noted above, section 104(a)(4) of CAPTA requires the Secretary to publish proposed priorities for research activities for public comment every 2 years. In response to this legislative mandate, CB has undertaken a review of the current legislative language, the results of the CAPTA-funded research since the last CAPTA announcement of research priority areas, findings from other relevant research, and input from the field. Based on this review, this notice of proposed research is being disseminated for comment. The FY 2018 President's Budget requested $32,937,267 for child abuse discretionary activities to support efforts designed to assist and enhance national, state, and local efforts to prevent, identify, and treat child abuse and neglect. The program funds projects to compile, publish, and disseminate training materials; provide technical assistance; and demonstrate and evaluate improved methods and procedures to prevent and treat child abuse and neglect. Under discretionary funds, CB will continue to fund the following clearinghouse and technical assistance activities:

• The Child Welfare Information Gateway;

• Family Resource Information, Education, and Network Development Service (FRIENDS); and

• National Child Abuse and Neglect Data System (NCANDS) technical assistance and technical support program.

In addition, the child abuse discretionary activities' account funds a number of research and demonstration grants and contracts. For those members of the public interested in responding to this announcement, information on previous and continuing projects supported by CB are available through the following websites:

A number of research topics are suggested in the 2010 reauthorization of CAPTA, section 104 (42 U.S.C. 5105). The legislation states that the Secretary shall, in consultation with other federal agencies and recognized experts in the field, carry out a continuing interdisciplinary program of research, including longitudinal research, that is designed to provide information needed to better protect children from abuse or neglect and to improve the well-being of victims of abuse or neglect, with at least a portion of such research being field initiated. Suggested research includes:

• The nature and scope of child abuse and neglect;

• The causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect, including the effects of child abuse and neglect on a child's development and the identification of successful early intervention services or other services that are needed;

• Effective approaches to improving the relationship and attachment of infants and toddlers who experience child abuse or neglect with their parents or primary caregivers in circumstances where reunification is appropriate;

• Appropriate, effective, and culturally sensitive investigative, administrative, and judicial systems, including multidisciplinary, coordinated decision making procedures with respect to cases of child abuse and neglect;

• The evaluation and dissemination of best practices, including best practices to meet the needs of special populations, consistent with the goals of achieving improvements in child protective services systems of the states in accordance with CAPTA, section 106(a), Grants to States for Child Abuse and Neglect Prevention and Treatment Programs [42 U.S.C. 5106a], paragraphs (1) through (14), which include:

i. The intake, assessment, screening, and investigation of reports of child abuse and neglect;

ii. Creating and improving the use of multidisciplinary teams and interagency, intra-agency, interstate, and intrastate protocols to enhance investigation, and improving legal preparation and representation; and improving legal preparation and representation;

iii. Case management, including ongoing case monitoring and delivery of services and treatment provided to children and their families;

iv. Enhancing the general child protective system by developing, improving and implementing risk and safety assessment tools and protocols, including the use of differential response;

v. Developing and updating systems of technology that support the program and track reports of child abuse and neglect from intake through final disposition and allow interstate and intrastate information exchange;

vi. Developing, strengthening and facilitating training;

vii. Improving the skills, qualifications, and availability of individuals providing services to children and families, and the supervisors of such individuals, through the child protection system, including improvements in the recruitment and retention of caseworkers;

viii. Developing, facilitating the use of, and implementing research-based strategies and training protocols for individuals mandated to report child abuse or neglect;

ix. Developing, implementing, or operating programs to assist in obtaining or coordinating necessary services for families of disabled infants with life threatening conditions;

x. Developing and delivering information to improve public education relating to the role and responsibilities of the child protection system and the nature and basis for reporting suspected incidents of child abuse and neglect, including the use of differential response;

xi. Developing and enhancing the capacity of community-based programs to integrate shared leadership strategies between parents and professionals to prevent and treat child abuse and neglect at the neighborhood level;

xii. Supporting and enhancing interagency collaboration between the child protection system and the juvenile justice system for improved delivery of services and treatment, including methods for continuity of treatment plans and services as children transition between systems;

xiii. Supporting and enhancing interagency collaboration among public health agencies, agencies in the child protective service system, and agencies carrying out private community-based programs

a. To provide child abuse and neglect prevention and treatment services (including linkages with education systems) and the use of differential response; and

b. To address the health needs, including mental health needs, of children identified as victims of abuse or neglect, including supporting prompt, comprehensive health and developmental evaluations for children who are the subject of substantiated child maltreatment reports; or

xiv. Developing and implementing procedures for collaboration among child protective services, domestic violence services, and other agencies in

a. Investigations, interventions, and the delivery of services and treatment provided to children and families, including the use of differential response, where appropriate; and

b. The provision of services that assist children exposed to domestic violence, and that also support the caregiving role of their non-abusing parents.

• Effective approaches to interagency collaboration between the child protection system and the juvenile justice system that improve the delivery of services and treatment, including methods for continuity of treatment plans and services as children transition between systems;

ii. (I) The medical community, including providers of mental health and developmental disability services; and

iii. (II) Providers of early childhood intervention services and special education for children who have been victims of child abuse or neglect;

• An evaluation of the redundancies and gaps in services in the field of child abuse and neglect prevention in order to make better use of resources;

• Effective collaborations, between the child protective system and domestic violence service providers, that provide for the safety of children exposed to domestic violence and their non-abusing parents that improve the investigations, interventions, delivery of services, and treatments provided for such children and families;

• The nature, scope, and practice of voluntary relinquishment for foster care or State guardianship of low-income children who need health services, including mental health services.

• The impact of child abuse and neglect on the incidence and progression of disabilities;

• The nature and scope of effective practices relating to differential response, including future analysis of the following:

i. What is the underlying hypothesis about the need to engage a parent and/or family in order to achieve specific outcomes in Child Protective Services (CPS)? Which specific outcomes need to be considered?

ii. Given that “engagement” may vary according to the eyes of the beholder, can specific aspects of engagement be measured with greater consistency and replication, particularly between the two groups who are part of the relationship?

iii. How should engagement be defined in future studies?

iv. CPS systems, in general, may be providing training to their caseworkers, regardless of pathway, to help them better relate to families and caregivers. If Alternative Response (AR) and Investigative Response (IR) caseworkers receive the same training and use similar engagement practices, should one still expect differences in family or caseworker perceptions of engagement?

v. Are there specific micro-practices that should be examined in more depth to determine if they make a difference for parents and families? As examples: Does setting an appointment to visit a family make a difference in engaging a family in early stages of relationship building? Does solution-focused casework result in parent willingness to engage with caseworkers?

vi. Should all low-risk families receive AR?

vii. Should the threshold for providing a family with AR be raised?

viii. Should CPS caseworkers also have the discretion to reassign IR families to AR?

ix. If families are encouraged to build relationships with their CPS caseworkers and are encouraged to contact them in the future, should re-referral still be considered a proxy for lack of safety?

• Child abuse and neglect issues facing Indians, Alaska Natives, and Native Hawaiians, including providing recommendations for improving the collection of child abuse and neglect data for Indian tribes and Native Hawaiian communities; or

• The information on the national incidence of child abuse and neglect specified in CAPTA, section 104(a) specified in clauses (i) through (x) of paragraph (1)(O).

B. Other Topics

Prevention Practices: CB is interested in research that builds on the existing body of knowledge of prevention practices, in particular primary prevention. This includes research to measure the efficacy and effectiveness of strategies to serve families across a spectrum of risk for child maltreatment, and strategies that aim to enhance the capacity of communities to address the physical, social, and emotional well-being of families before the occurrence of child abuse or neglect. In addition, CB is interested in research that examines innovative techniques for the assessment and detection of the risk of incidences of child abuse and neglect, including techniques for the detection of household opioid and other substance misuse, and interventions based on such risk detection which mitigate or eliminate the incidence of abuse and neglect.

CB has supported a number of research and demonstration projects to generate knowledge about effective early prevention strategies and interventions. Over 5 years, from 2009-2014, CB funded the Rigorous Evaluation of Existing Child Abuse and Neglect Prevention Programs grant programs. Through a competitive process, grants were made to conduct randomized controlled trials (RCTs) of four well-established, community-based child abuse and neglect prevention programs located in three regions across the U.S., garnering information on the effectiveness of interventions to increase child, parent, and family safety and well-being. Additionally, CB has funded research and demonstration grants to support initiatives to prevent maltreatment and increase the well-being of children and youth, including: Infrastructure-building grants between child welfare agencies, early education, and schools; supportive housing models for families; and interventions to address child trafficking. While this work is contributing to the body of knowledge about the type and range of early intervention strategies to prevent the occurrence of maltreatment, much more can and must be learned at the individual and population level to build the protective capabilities of families and communities.

Research interests may include: The development and demonstration of research methodologies that allow for valid and reliable measurement of primary prevention activities and assessment of risk for child abuse and neglect at the individual, community, and population level; the innovative use of data, including administrative and secondary data, to inform our understanding of the implementation and outcomes of primary prevention strategies; and integrating child abuse and neglect research into prevention practices and techniques for the assessment and detection of risk for child abuse and neglect.

Child Protection Systems: CB is interested in research that examines effective state-level strategies employed to improve child protection systems. Questions may include: The degree to which changes in CPS systems' policy and practice are tied to better outcomes; determining the variations in local agencies that result in different outcomes; and whether or not child safety and well-being are improved by privatizing part or all of the child welfare system. Other research interests may include: Effective responses for children at risk of being harmed; barriers to consistency in CPS operations, such as differences in the level of resources; lack of clear laws and policy and the competing desire for local autonomy in government functions; the means by which CPS agencies try to understand the standards of the community they serve through outreach to additional panels and review teams (fatality review team, citizen review panels, external case reviews); and collaborations between CPS and other agencies.

Services: CB is interested in research focused on the assessment of service needs and services provided. Research questions may include: What services are children and families receiving; to what degree are services responsive to the needs of the target population; and what are the outcomes that result from various services. Other research may focus on case planning and intervention, such as examining the development and implementation of comprehensive family assessment, safety planning, engaging families and monitoring risk assessment over the life of CPS cases, and increasing knowledge of parent and child engaging in the case planning process. In addition, topics of interest include services needs of families and children who are impacted by substance use disorders, trafficking, and inadequate housing including homelessness.

The findings from the most recent Child and Family Service Reviews (CFSR) identify strengths and needs within state programs, as well as areas where technical assistance can lead to program improvements. CB encourages research on underlying issues in practice areas contributing to poor performance on CFSR outcomes. State performance on identifying, assessing, and addressing children's mental needs, in particular, was found as an area needing improvement in the CFSRs. Areas of interest for research may include examining CPS procedures for identifying, assessing, and responding to children's mental health challenges, as well as the prevalence, type, and severity of mental health needs among children identified in state child welfare systems. In addition, findings from the National Survey of Child and Adolescent Well-Being show that high rates of mental health needs among parents, coupled with low rates of identification, assessment, and referral, is a serious issue. CB is interested in research that examines support services to strengthen families, including mental health services to parents and children.

Secondary Data Analysis: CB encourages the utilization of existing data sources, particularly the use of service data through the National Child Abuse and Neglect Data System (NCANDS) and other child welfare data available through the National Data Archive on Child Abuse and Neglect. CB is interested in secondary data analyses using NCANDS, focusing on service utilization, recurrence, and perpetrators.

Service utilization: While not all states provide complete service data to NCANDS, for those states that do provide complete service data, the following areas could be examined: The services that are provided to Substance Exposed Newborns and their families; services to victims of human trafficking; differences in service patterns that exist between child victims who remain in their homes and those who are removed; and the variations in service patterns within states according to county characteristics.

Perpetrators: CB continues to be interested in perpetrators, with the notion that understanding who this group is and what their characteristics are can help to inform more effective intervention and prevention efforts. According to the most recent analysis of NCANDS data, female caregivers between the ages of 18-30 are most often identified as maltreators of children ages birth-3. Further exploration of these phenomena is necessary to identify subgroups within this population of female caregivers, to identify services that mitigate risk to infants and toddlers of young adult parents, and to develop targeted prevention strategies.

Field Initiated Research on Child Abuse and Neglect

The generation of new knowledge for understanding critical issues in child abuse and neglect improves prevention, identification, assessment, and treatment. Research areas to be addressed may be those that will expand the current knowledge base, build on prior research, contribute to practice enhancements, inform policy, improve science, and provide insights into new approaches to the assessment, prevention, intervention, and treatment of child maltreatment (i.e., physical abuse, sexual abuse, emotional maltreatment, or neglect) on any of the topics listed in (A) Legislative Topics, (B) Other Topics, above, or any other child maltreatment topic. In addition to the topics cited above, practitioners and researchers are encouraged to propose other relevant subjects for research topics in child abuse and neglect.

National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY.

DATES:

Only written comments and/or applications for a license which are received by the National Center for Advancing Translational Sciences on or before July 10, 2018 will be considered.

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America and the University of North Carolina at Chapel Hill.

The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of Licensed Patent Rights for the following: “Therapeutics for cancers in humans which result from or characterized by the presence of mutant IDH1.”

The inventions relate to a series of novel compounds that potently and selectively inhibit mIDH1. These compounds reduce 2-HG levels in cell lines in vitro as well as in human cancer cells grown in mouse xenografts in vivo. These compounds show greater than 250-fold selectivity for the mutant enzyme over the wild-type, show favorable in vitro stability (in mouse, rat, dog and human hepatocyte exposure studies), are AMES negative, and exhibit no significant metabolic CYP liabilities. These compounds possess very favorable in vivo rodent pharmacokinetics and bioavailability and are well tolerated in rodents, even when dosed at high levels.

Thus, the compounds of the subject inventions can be used individually or in combination to develop new therapies to treat diseases which result from mutant IDH1 activity. The diseases caused by mutant IDH1 activity include cancer (e.g., acute myeloid leukemia, glioma, cholangiocarcinoma and potentially other solid tumors) and selected rare diseases, such as Ollier Disease.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Center for Advancing Translational Sciences receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Exclusive Patent License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0096, Report of Oil or Hazardous Substance Discharge and Report of Suspicious Maritime Activity; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES:

Comments must reach the Coast Guard on or before August 24, 2018.

ADDRESSES:

You may submit comments identified by Coast Guard docket number [USCG-2018-0282] to the Coast Guard using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public participation and request for comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

A copy of the ICR is available through the docket on the internet at http://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710, Washington, DC 20593-7710.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0282], and must be received by August 24, 2018.

Submitting Comments

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Summary:Any discharge of oil or a hazardous substance must be reported to the National Response Center (NRC) so that the pre-designated on-scene coordinator can be informed and appropriate spill mitigation action carried out. The NRC also receives suspicious activity reports from the public and disseminates this information to appropriate entities.

Need: Titles 33 CFR 153.203, 40 CFR 263.30 and 264.56, and 49 CFR 171.15 mandate that the NRC be the central place for the public to report all pollution spills. Title 33 CFR 101.305 mandates that owners or operators of those vessels or facilities required to have security plans, report activities that may result in a Transportation Security Incident (TSI) or breaches of security to the NRC. Voluntary reports are also accepted.

Forms: None.

Respondents: Persons-in-charge of a vessel or onshore/offshore facility; owners or operators of vessels or facilities required to have security plans; and the public.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has decreased from 3,144 hours to 1,980 hours a year due to a decrease in the estimated annual number of responses.

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for the following collection of information: 1625—NEW, Coast Guard Art Program Membership Application Form. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES:

Comments must reach the Coast Guard on or before August 24, 2018.

ADDRESSES:

You may submit comments identified by Coast Guard docket number [USCG-2018-0136] to the Coast Guard using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public participation and request for comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

A copy of the ICR is available through the docket on the internet at http://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710, Washington, DC 20593-7710.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek approval for the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0136], and must be received by August 24, 2018.

Submitting Comments

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Information Collection Request

Title: Coast Guard Art Program Membership Application Form.

OMB Control Number: 1625—NEW.

Summary: This collection of information contains the application form for membership and samples of artwork for those wishing to become Coast Guard Art Program (COGAP) member artists.

Need: The application and samples of artwork are needed to determine if the applicant has the necessary artistic skills and ability to become a contributing member of the COGAP. The authority to collect this information is contained in 5 U.S.C. 301, Departmental regulations; 14 U.S.C. 93(a)(6), Commandant general powers; and 44 U.S.C. 3101, Records management by agency heads.

Forms: CG-5700, Membership Application Form.

Respondents: Artist interested in becoming contributing member of the Coast Guard Art Program.

Frequency: Annually.

Hour Burden Estimate: This is a new collection. The estimated burden is 10 hours a year.

We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Hunting and Shooting Sports Conservation Council (HSSCC), in accordance with the Federal Advisory Committee Act. The HSSCC's purpose is to provide recommendations to the Federal Government, through the Secretary of the Interior and the Secretary of Agriculture, regarding policies and endeavors that benefit wildlife resources; encourage partnership among the public; sporting conservation organizations; and Federal, state, tribal, and territorial governments; and benefit recreational hunting and recreational shooting sports.

DATES:

Meeting: Wednesday, July 11, 2018, from 10:30 a.m. to 5 p.m. The meeting is open to the public. Deadline for Attendance or Participation: For security purposes, signup or request for accommodations is required no later than July 3, 2018. For more information, contact the HSSCC Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). For participation during the meeting, see Public Input under SUPPLEMENTARY INFORMATION.

Comment Submission: You may submit written comments in advance of the meeting by emailing them to the HSSCC Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT).

FOR FURTHER INFORMATION CONTACT:

Douglas Hobbs, Designated Federal Officer, HSSCC, by telephone at (703) 358-2336, or by email at doug_hobbs@fws.gov. The U.S. Fish and Wildlife Service is committed to providing access to this meeting for all participants. Please direct all requests for sign language interpretation service, closed captioning, or other accommodations to Douglas Hobbs by close of business on Friday, July 3, 2018. If you are hearing impaired or speech impaired, contact Douglas Hobbs via the Federal Relay Service at 800-877-8339.

SUPPLEMENTARY INFORMATION:

We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Hunting and Shooting Sports Conservation Council (HSSCC). The HSSCC was established to further the provisions of the Fish and Wildlife Act of 1956 (16 U.S.C. 742a), the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701), the National Wildlife Refuge System Improvement Act of 1997 (16 U.S.C. 668dd), other Acts applicable to specific bureaus, and Executive Order 13443 (August 17, 2007), “Facilitation of Hunting Heritage and Wildlife Conservation.” The council's membership is composed of 18 discretionary members. The HSSCC's purpose is to provide recommendations to the Federal Government, through the Secretary of the Interior and the Secretary of Agriculture, regarding policies and endeavors that (a) benefit wildlife resources; (b) encourage partnership among the public; sporting conservation organizations; Federal, state, tribal, and territorial governments; and (c) benefit recreational hunting and recreational shooting sports.

Meeting Agenda

• Overview and update on the implementation of outdoor recreation Secretarial Orders.

• Update from Department of the Interior and Department of Agriculture and bureaus from both agencies regarding efforts to create or expand hunting and recreational shooting opportunities on Federal lands.

• Overview of Federal programs that benefit species and habitat conservation and outdoor recreation opportunities, particularly hunting and the shooting sports.

• Public comment period.

The final agenda and other related meeting information will be posted on the HSSCC website at http://www.fws.gov/hsscc. The Designated Federal Officer will maintain detailed minutes of the meeting, which will be posted for public inspection within 90 days after the meeting at http://www.fws.gov/hsscc.

Public InputIf you wish to:You must contact the Council Designated Federal Officer (see

FOR FURTHER INFORMATION CONTACT)

no later than:

Attend the meetingJuly 3, 2018.Submit written information before the meeting for the Council to consider during the meetingJuly 3, 2018.Give an oral presentation during the public comment periodJuly 3, 2018.Submitting Written Information

Interested members of the public may submit relevant information for the Council to consider during the public meeting. Written statements must be received by the date in Public Input, so that the information may be made available to the Council for their consideration prior to this meeting. Written statements must be supplied to the Council Designated Federal Officer in the following formats: One hard copy with original signature, and/or one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, MS PowerPoint, or rich text file).

Giving an Oral Presentation

Depending on the number of people wishing to comment and the time available, the amount of time for individual oral comments may be limited. Interested parties must contact the Council Designated Federal Officer, in writing (preferably via email; see FOR FURTHER INFORMATION CONTACT), to be placed on the public speaker list for this meeting. Registered speakers who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, may submit written statements to the Council Designated Federal Officer up to 30 days following the meeting. Requests to address the Council during the public comment period will be accommodated in the order the requests are received.

Availability of Public Comments

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Exxon Valdez Oil Spill Trustee Council is soliciting nominations for the Public Advisory Committee, which advises the Trustee Council on decisions related to the planning, evaluation, funds allocation, and conduct of injury assessment and restoration activities related to the T/V Exxon Valdez oil spill of March 1989. Public Advisory Committee members will be selected and appointed by the Secretary of the Interior to serve a 2-year term.

The Exxon Valdez Oil Spill Public Advisory Committee was created by Paragraph V.A.4 of the Memorandum of Agreement and Consent Decree entered into by the United States of America and the State of Alaska on August 27, 1991, and approved by the United States District Court for the District of Alaska in settlement of United States of America v. State of Alaska, Civil Action No. A91-081 CV. The Public Advisory Committee was created to advise the Trustee Council on matters relating to decisions on injury assessment, restoration activities, or other use of natural resource damage recoveries obtained by the government.

The Trustee Council consists of representatives of the U.S. Department of the Interior, U.S. Department of Agriculture, National Oceanic and Atmospheric Administration, Alaska Department of Fish and Game, Alaska Department of Environmental Conservation, and Alaska Department of Law.

The Public Advisory Committee consists of 10 members to reflect balanced representation from each of the following principal interests: Aquaculture/mariculture, commercial tourism, conservation/environmental, recreation, subsistence use, commercial fishing, native landownership, sport hunting/fishing, science/technology, and public-at-large.

Nominations for membership may be submitted by any source.

Nominations should include a résumé providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Public Advisory Committee and permit the Department of the Interior to contact a potential member.

Individuals who are federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest.

Public Availability of Comments: Before including your address, phone number, email address, or other personal identifying information in your nomination/comment, you should be aware that your entire nomination/comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your nomination/comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection.

DATES:

Interested persons are invited to submit comments on or before August 24, 2018.

ADDRESSES:

Send your comments on this information collection request (ICR) by mail to the U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to jesonnem@blm.gov. Please reference OMB Control Number 1004-0025 in the subject line of your comments.

FOR FURTHER INFORMATION CONTACT:

To request additional information about this ICR, contact Elaine Guenaga by email at eguenaga@blm.gov, or by telephone at (202) 912-7345.

SUPPLEMENTARY INFORMATION:

In accordance with the Paperwork Reduction Act of 1995, the BLM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format. We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: The General Mining Law (30 U.S.C. 29, 30, and 39) authorizes a holder of an unpatented claim for hardrock minerals to apply for fee title (patent) to the Federal land (as well as minerals) embraced in the claim. Since 1994, a rider on the annual appropriation bill for the Department of the Interior has prevented the BLM from processing mineral patent applications unless the applications were grandfathered under the initial legislation. While grandfathered applications are rare at present, the approval to collect the information continues to be necessary because of the possibility that the moratorium will be lifted.

Respondents/Affected Public: Owners of unpatented mining claims and mill sites upon the public lands, and of reserved mineral lands of the United States, National Forests, and National Parks.

Total Estimated Number of Annual Respondents: 10.

Total Estimated Number of Annual Responses: 10.

Estimated Completion Time per Response: Varies from 3 to 100 hours, depending on activity.

Total Estimated Number of Annual Burden Hours: 559.

Respondent's Obligation: Required to obtain or maintain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: $174,375.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Jean Sonneman,Information Collection Clearance Officer, Bureau of Land Management.[FR Doc. 2018-13582 Filed 6-22-18; 8:45 am] BILLING CODE 4310-84-PDEPARTMENT OF THE INTERIORBureau of Land Management[LLWO35000.L14400000.PN0000; OMB Control Number 1004-0153]Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Conveyance of Federally-Owned Mineral InterestsAGENCY:

Bureau of Land Management, Interior.

ACTION:

Notice of information collection; request for comment.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection.

DATES:

Interested persons are invited to submit comments on or before July 25, 2018.

ADDRESSES:

Send written comments on this Information Collection Request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at OIRA_Submission@omb.eop.gov; or via facsimile to (202) 395-5806. Please provide a copy of your comments to the U.S. Department of the Interior, BLM, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to jesonnem@blm.gov. Please reference OMB Control Number 1004-0153 in the subject line of your comments.

FOR FURTHER INFORMATION CONTACT:

To request additional information about this ICR, contact Chantel Jordan by email at cmjordan@blm.gov, or by telephone at 202-912-7514. You may also view the ICR at http://www.reginfo.gov/public/do/PRAMain.

SUPPLEMENTARY INFORMATION:

In accordance with the Paperwork Reduction Act of 1995, the BLM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

A Federal Register notice with a 60-day public comment period soliciting comments on this collection of information was published on January 16, 2018 (83 FR 2183). The comment period closed on March 19, 2018. On April 11, 2018, 23 days after the comment period closed, the BLM received two comments via email. The comments referred specifically to the Bears Ears National Monument.

Except for the mention of the OMB control number in the title of each comment, the comments did not mention the information collection, and the BLM has taken no action to revise the information collection in response to the comments. The BLM Information Collection Clearance Officer has forwarded the comments to the appropriate BLM staff for consideration.

The BLM is again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: Section 209(b) of the Federal Land Policy and Management Act (43 U.S.C. 1719) authorizes the Secretary of the Interior to convey Federally-owned mineral interests to non-Federal owners of the surface estate. The respondents in this information collection are non-Federal owners of surface estates who apply for underlying Federally-owned mineral interests. This information collection enables the BLM to determine if the applicants are eligible to receive title to the Federally-owned mineral interests beneath their lands. Regulations at 43 CFR part 2720 establish guidelines and procedures for the processing of these applications.

Celia Feldpausch (202-205-2387), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for these investigations may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

SUPPLEMENTARY INFORMATION:

Effective January 23, 2018, the Commission established a general schedule for the conduct of the final phase of its investigations on stainless steel flanges from China and India,1 following a preliminary determination by the U.S. Department of Commerce (“Commerce”) that imports of the subject stainless steel flanges were subsidized by the government of China. Notice of the scheduling of the final phase of the Commission's investigations and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of February 7, 2018 (83 FR 5459). The hearing was held in Washington, DC, on April 10, 2018, and all persons who requested the opportunity were permitted to appear in person or by counsel. To date, Commerce has issued final affirmative determinations with respect to the subject stainless steel flanges from China.2 3 The Commission subsequently issued its final affirmative determination regarding subsidized imports from China on May 29, 2018 (83 FR 25714, June 4, 2018). The Commission currently is issuing a supplemental schedule for its antidumping duty investigation on imports of stainless steel flanges from China.

1Stainless Steel Flanges from China and India: Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations, 83 FR 5459, February 7, 2018.

3Stainless Steel Flanges From the People's Republic of China: Final Affirmative Determination of Sales at Less than Fair Value, 83 FR 26959, June 11, 2018.

This supplemental schedule is as follows: The deadline for filing supplemental party comments on Commerce's final antidumping duty determination regarding China is June 25, 2018. Supplemental party comments may address only Commerce's final antidumping duty determination regarding imports of certain stainless steel flanges from China. These supplemental final comments may not contain new factual information and may not exceed five (5) pages in length. The supplemental staff report in this antidumping duty investigation will be placed in the nonpublic record and a public version will be issued thereafter.

For further information concerning these investigations, see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).

Authority:

These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.

On the basis of the record 1 developed in the subject five-year review, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that revocation of the antidumping duty order on tin- and chromium-coated steel sheet from Japan would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.

1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).

Background

The Commission, pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)), instituted this review on May 1, 2017 (82 FR 20378) and determined on August 4, 2017 that it would conduct a full review (82 FR 40168, August 24, 2017). Notice of the scheduling of the Commission's review and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register on October 20, 2017 (82 FR 49661). The hearing was held in Washington, DC, on February 27, 2018, and all persons who requested the opportunity were permitted to appear in person or by counsel.

The Commission made this determination pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determination in this review on June 19, 2018. The views of the Commission are contained in USITC Publication 4795 (June 2018), entitled Tin- and Chromium-Coated Steel Sheet from Japan: Investigation No. 731-TA-860 (Third Review).

On March 29, 2017, the Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA), issued an Order to Show Cause to Mohammed Asgar, M.D. (hereinafter, Respondent), of Gary, Indiana.1 GX 6 (Order to Show Cause), at 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration as a practitioner, on the ground that the U.S. Department of Health and Human Services, Office of Inspector General (hereinafter, HHS OIG) notified Respondent of his “mandatory exclusion from participation in all Federal health care programs for a minimum period of five years pursuant to 42 U.S.C. 1320a-7(a).” Id. at 2 (citing 21 U.S.C. 824(a)(5)). The Show Cause Order also proposed the denial of any pending application by Respondent to modify or renew his registration. Id. at 1.

1 The Show Cause Order caption also listed an address in Posen, Illinois for Respondent.

As for the Agency's jurisdiction, the Show Cause Order alleged that Respondent holds DEA Certificate of Registration No. FA3926055, which authorizes him to dispense controlled substances in schedules II through V as a practitioner, at the registered address of 600 Grant Street, Gary, Indiana 46402. Id. The Show Cause Order alleged that this registration expires on June 30, 2019. GX 6, at 2.

As to the substantive ground for the proceeding, the Show Cause Order specifically alleged that Respondent was “notified by . . . [the HHS OIG] of . . . [his] mandatory exclusion from participation in all Federal health care programs for a minimum period of five years pursuant to 42 U.S.C. 1320a-7(a).” GX 6, at 2. It asserted that, “[m]andatory exclusion from Medicare is an independent ground for revoking a DEA registration pursuant to 21 U.S.C. 824(a)(5).” Id. The Show Cause Order further asserted that “although your conviction was unrelated to your handling of controlled substances, DEA has nevertheless found that the underlying conviction forming the basis for a registrant's exclusion from participating in federal health care programs need not involve controlled substances for revocation under 21 U.S.C. 824(a)(5)” to be warranted. Id.

The Show Cause Order notified Respondent of his right to request a hearing on the allegations, or to submit a written statement in lieu of a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. at 2-3 (citing 21 CFR 1301.43). The Show Cause Order also notified Respondent of his right to submit a corrective action plan under 21 U.S.C. 824(c)(2)(C). Id. at 3.

By letter dated April 27, 2017, Respondent's counsel acknowledged service of the Show Cause Order on April 4, 2017, waived Respondent's right to a hearing, and stated that he was filing Respondent's written response to the Show Cause Order. GX 7 (Written Statement), at 1. Attached to the Written Statement are the Show Cause Order, 22 letters “submitted voluntarily by patients and colleagues” of Respondent, the transcript of Respondent's Sentencing Hearing, and the Government's Sentencing Memorandum concerning Respondent. Id. at 2.

On October 13, 2017, DEA submitted a Request for Final Agency Action (RFAA) including an evidentiary record to support the Show Cause Order's allegations and Respondent's Written Statement and attachments.

I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact.

Findings of FactRespondent's DEA Registration

Respondent is the holder of DEA Certificate of Registration No. FA3926055, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of 600 Grant Street, Gary, Indiana 46402. GX 1 (copy of registration); GX 2 (Certification of Registration Status), at 1. This registration expires on June 30, 2019. GX 1; GX 2, at 1.

The Nature and Scope of Respondent's Criminality

Respondent's criminal conduct began in Chicago in or about 2005. GX 3 (Plea Agreement, United States v. Asgar, No. 12 CR 491-10 (N.D. Ill. Dec. 18, 2014) (hereinafter, Plea Agreement)), at 2. At this time, Respondent and another medical doctor, Dr. Farzana Begum, “conspired with each other to knowingly and willfully refer Medicare beneficiaries to Grand Home Health for the provision of home health care services in exchange for illegal cash kickback payments.” Id. at 2-3. Each Medicare patient that the doctors referred resulted in a cash payment of $400 to Dr. Begum. Id. at 3. According to the Plea Agreement, Respondent “knew that it was illegal to solicit and receive kickbacks . . . in exchange for . . . referrals of Medicare patients.” Id. “From in or about January 2006 through May 2008,” Dr. Begum received about “$141,100 in kickbacks in exchange for [Respondent's] referral of Medicare beneficiaries to Grand Home Health.” Id.

The relationship between Respondent and Dr. Begum ended in approximately May 2008. Id. As a result, Respondent ended the arrangement under which Dr. Begum received cash kickbacks in exchange for Respondent's Medicare patient referrals. Id.

About six months later, however, the cash kickback payments resumed. This time, Respondent received cash kickbacks in exchange for his referral of Medicare patients to Grand Home Health. Id. On or about February 9, 2011, for example, Respondent received $1,500 in cash for his referral of three patients to Grand Home Health “for the furnishing of home health care services for which payment may be made in whole and in part under Medicare.” Id. at 3-4. For the two-year period between about February 2009 and February 2011, Respondent received about $15,900 in exchange for his referral of Medicare beneficiaries to Grand Home Health. Id. at 4.

By May 2011, the Government was investigating the conspiracy. Id. On or about May 3, 2011, Respondent met with an individual who was cooperating with the investigation and recording the meeting. Id. During the meeting, Respondent received about $1,500 in exchange for the referral of three Medicare patients to Grand Home Health. Id.

At another meeting that was recorded by a different individual, Respondent urged the individual to “deny right away” if anyone raised the kickback conspiracy. Id. Respondent said, “So that's the story, okay?” as he apparently sought to confirm that the individual would call such a claim a lie and say “nothing . . . happened.” Id.; see also GX 7 (Government's Sentencing Memorandum, United States v. Asgar, No.-12 CR 491-10 (N.D. Ill June 7, 2016) (hereinafter, Government Sentencing Memo), at 2-3 (After law enforcement discovered the Grand Home Health Care scheme, Asgar was recorded cautioning the owner of Grand Home Health Care about keeping records of the kickback payments, probing for information related to law enforcement's discovery of the scheme, and assuring the owner that, “I have to be a little careful now, listen when you're cleared, I will start [referring patients], ok?”).

In total, from about January 1, 2006 through March 31, 2011, Medicare paid about $201,635 for claims submitted for home health services provided to the Medicare patients that Respondent referred to Grand Home Health in exchange for illegal kickbacks. GX 3, at 5. From about January 1, 2006 through May 31, 2008, Medicare paid about $1,002,728 for claims submitted for home health services provided to the Medicare beneficiaries that Dr. Begum referred to Grand Home Health in exchange for illegal kickbacks. Id. Thus, “Grand Home Health earned approximately $317,952 in net proceeds from these illegally referred patients.” Id. According to the Plea Agreement, Respondent acknowledged these facts. Id.

In addition to the above, beginning in or about 2008, Respondent agreed to refer Medicare beneficiaries to “Company A” for home health care services in exchange for illegal cash kickbacks from “Individual A.” Id. at 6. Pursuant to this conspiracy, Respondent typically received about $500 per patient referral. Id. In total, Respondent solicited and received about $74,000 in cash kickbacks in exchange for his referral of Medicare patients to Company A between about 2008 and August 2011. Id. Medicare paid about $1,725,762 for claims submitted by Company A for home health services provided to the Medicare patients whom Respondent referred in exchange for illegal kickbacks. Id. Company A received about $146,689 in net proceeds from the patients Respondent illegally referred. Id. According to the Plea Agreement, Respondent acknowledged the amounts Medicare paid to Company A during this phase of the illegal cash kickback conspiracy in which he participated. Id.

The Plea Agreement: On December 18, 2014, Respondent, Respondent's attorney, the United States Attorney for the Northern District of Illinois, and an Assistant U.S. Attorney signed a Plea Agreement. GX 3, at 22. Respondent agreed to plead guilty to “conspiracy to commit an offense against the United States, namely, conspiring to solicit and receive kickbacks, in violation of Title 42, United States Code, Section 1320a-7b(b)(1)(A), all in violation of Title 18, United States Code, Section 371.” Id. at 1. In sum, Respondent's criminality consisted of a multi-year conspiracy involving more than $2.9 million of Medicare payments to two home health care companies and the netting of hundreds of thousands of dollars in kickbacks by doctors involved in this conspiracy. GX 3, at 2-6.

According to the Plea Agreement, Respondent “has clearly demonstrated a recognition and affirmative acceptance of personal responsibility for his criminal conduct.” Id. at 9. Moreover, the Plea Agreement includes language giving Respondent credit for acceptance of responsibility pursuant to the United States Sentencing Guidelines, § 3E1.1(b). Id. at 10. This provision of the Plea Agreement provides that “if the Court determines that the defendant is entitled to a two-level reduction for acceptance of responsibility, the government will move for an additional one-level reduction in the offense level.” Id. Further, in the Plea Agreement, Respondent agreed to full and truthful cooperation “in any matter in which he is called upon to cooperate” by the Chicago U.S. Attorney's Office. Id. at 12. The expected cooperation included “providing complete and truthful information in any investigation and pre-trial preparation and complete and truthful testimony in any criminal, civil, or administrative proceeding.” Id.

At some point, Respondent appeared before the United States District Court and pled guilty to the charge. The District Court accepted his plea.

The Government Sentencing Memo: Respondent's counsel attached the Government's Sentencing Memo to his Written Statement. According to the Government's Sentencing Memo, Respondent “took advantage of the faith and commitment of his patients in order to extract benefits for himself to which he knew he was not entitled. In doing so, he abused his position as their trusted doctor for his own pecuniary advantage, knowing that it was wrong all along.” GX 7, Government's Sentencing Memo, at 6. According to the Government's Sentencing Memo, Respondent treated his “patients as a commodity to be traded . . . for additional, secret profits,” id. at 7, subjugating his patients' interests to his own greed, since he did not need the money given he “was earning more than half a million dollars per year,” according to “what was actually reported on . . . [Respondent's] tax returns.” Id. at 6.

The Government's Sentencing Memo states that, while Respondent “appeared to have no plans to stop committing his crime prior to being approached by law enforcement, he did accept responsibility for his actions immediately.” Id. at 5. Elsewhere, the Government's Sentencing Memo states that Respondent “has unquestionably taken full responsibility for his action [sic] going so far as to provide significant cooperation to the [G]overnment after his arrest.” Id. at 7. Respondent's “significant cooperation,” according to the Sentencing Memo, consisted of “conduct[ing] two recordings that were ultimately used . . . in the investigation and prosecution of administrators and physicians,” testifying at two trials “over the course of multiple days and participat[ing] in numerous preparation sessions during the course of his cooperation,” and providing law enforcement with “information regarding other corrupt home health entities and doctors that the [G]overnment was able to use” in other investigations. Id. at 5-6. The Sentencing Memo states that Respondent's “significant cooperation” was the reason it was recommending a lower sentence than it otherwise would have recommended, given that Respondent “took advantage of the faith and commitment of his patients in order to extract benefits for himself to which he knew he was not entitled.” Id. at 6.

Respondent's Sentencing Hearing: Respondent also attached the Transcript of Sentencing Hearing to the Written Statement. When Respondent took advantage of his right to speak at his Sentencing Hearing, he stated that “it has been a long, rough and stressful five years for me and my family.” GX 7 (Transcript of Proceedings—Sentencing Hearing at 38-39, United States v. Asgar, No.-12 CR 491-10 (N.D. Ill. June 15, 2016) (hereinafter, Transcript of Sentencing Hearing). Regarding acceptance of responsibility, Respondent stated that, “Over this period my character and reputation that was at the peak slid down to the bottom as a consequence of my wrongdoing, for which I deeply regret, and accept full responsibilities.” Id. at 39. He emphasized that he “cooperated and helped the [G]overnment in every way possible to successfully bring to an end one of the biggest and high profile medical scandals in Illinois history.” Id. Respondent stated that his cooperation with the investigation included “recording of conversation [sic] with medical personnel, administrative officers, meeting with prosecutors, federal agents, lengthy trial, trial preparations and testifying at trials.” Id.

An Assistant United States Attorney (hereinafter, AUSA) also addressed the Court at Respondent's Sentencing Hearing. He agreed that Respondent cooperated with the criminal investigation and reiterated that Respondent's cooperation was “one of the essential factors in mitigation.” Id. at 31. He stated that Respondent “has also undertaken significant steps to make amends.” Id. at 37.

The AUSA also addressed aggravating factors. He stated that Respondent's crime involved “betrayal of patients' trust[, and] . . . betrayal of larger society, which places trust in doctors to do the right thing [-] to put the patients over their own personal pecuniary gains.” Id. at 34. The AUSA stated that, “for reasons that may be simply greed,” Respondent was among those “willing to trade off the trust that their patients and their society placed in them and trade that for financial gain.” Id. at 36. The AUSA stated that doctors “occupy a special place in our society” and criminal sentences “do have a real deterrent effect.” Id. He urged the Court to “send a message” that “[i]f you violate the anti-kick back [sic] statute, if you conspire to turn your patients into chips to be turned in, there are repercussions.” Id.

During the sentencing hearing, the Court repeatedly referenced Respondent's greed and obstruction of justice. The Court pointed out that Respondent “probably . . . had the most lucrative practice going at the time.” Id. at 33. Yet, the Court stated, “on top of that,” Respondent was “helping himself to the kickbacks.” Id. Further, the Court stated, agreeing with the AUSA, that despite “inflection points, . . . times when someone would have caught themselves maybe and said, `Eh, I'm out,' ” Respondent, instead, wanted to “cover it up.” Id. at 33-34. The “obstruction piece on top of it,” the Court stated, “compounds that a little bit.” Id. at 34.

Based on the uncontroverted evidence in the record, I find that Respondent participated in multi-year illegal kickback conspiracies involving the payment of about $230,900 in illegal kickbacks to himself and his co-conspirator, and of Medicare claims of over $2.9 million.

In addition, I find that, during the criminal investigation, Respondent urged another doctor “to lie if asked whether that doctor had ever provided patients in return for money.” GX 7 (Government Sentencing Memo) at 3; see also GX 3, at 4. Thus, I find, as the District Judge found, that Respondent sought to obstruct justice.

While Respondent, according to the Government Sentencing Memo, “appeared to have no plans to stop committing his crime prior to being approached by law enforcement, he did accept responsibility for his actions immediately.” GX 7 (Sentencing Memo, at 5); see also id. at 8-9 (Respondent's “cooperation in this case and his immediate acceptance of responsibility demonstrate not only an acknowledgement of his wrongdoing, but a sincere effort to take steps to make amends for the crime that [he] has committed.”). Thus, I find, based on the record as a whole, including the plea agreement; the statements by the prosecutor handling the criminal case, both in the Government's Sentencing Memo (stating that Respondent had “acknowledged the full scope of his lengthy criminal conduct,” GX 7 (Sentencing Memo, at 3) and at the sentencing hearing; and the District Court's acceptance of the guilty plea, the plea agreement, and application of the sentencing guidelines reductions based on his acceptance of responsibility; that Respondent accepted responsibility for his criminality.

By letter dated September 30, 2016, a Health Care Program Exclusions Reviewing Official of the HHS OIG notified Respondent that he was “being excluded from participation in any capacity in the Medicare, Medicaid, and all Federal health care programs as defined in section 1128B(f) of the Social Security Act . . . for a minimum period of 5 years.” GX 5, at 1 (hereinafter, HHS Exclusion Letter), also citing 42 U.S.C. 1320a-7(a). The HHS Exclusion Letter explained that Respondent's exclusion was “due to . . . [his] conviction . . . of a criminal offense related to the delivery of an item or service under the Medicare or a State health care program.” Id. It stated that Respondent's exclusion is “effective 20 days from the date of this letter.” Id.

As 42 U.S.C. 1320a-7(a) makes clear, Respondent's conviction subjected him to the mandatory exclusion provision, and in his Written Statement, Respondent admits that he has been mandatorily excluded under 42 U.S.C. 1320a-7(a). I find, therefore, that Respondent has been excluded under the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a). Based on the terms of the HHS Exclusion Letter, uncontroverted by evidence in the record, I further find that Respondent's period of exclusion is still in effect.

Discussion

Pursuant to 21 U.S.C. 824(a)(5), the Attorney General may suspend or revoke a registration issued under section 823 of Title 21, “upon a finding that the registrant . . . has been excluded . . . from participation in a program pursuant to section 1320a-7(a) of Title 42.” Further, “It is well established that the various grounds for revocation or suspension of an existing registration that Congress enumerated in [§ 824(a)] are also properly considered in deciding whether to grant or deny an application under [§ 823].” Arthur H. Bell, D.O., 80 FR 50035, 50037 (2015) (citing The Lawsons, Inc., 72 FR 74334, 74337 (2007); Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, M.D., 63 FR 45260 (1998); Kuen H. Chen, M.D., 58 FR 65401, 65402 (1993)); see also Serling Drug Co. and Detroit Prescription Wholesaler, Inc., 40 FR 11918, 11919 (1975) (consistent Agency precedent has held that the CSA does not require the Agency to indulge in the useless act of granting a license on one day only to withdraw it on the next).

Agency precedent has made clear that revocation under 21 U.S.C. 824(a)(5) may be appropriate regardless of whether or not the misconduct that led to the mandatory exclusion involved controlled substances. KK Pharmacy, 64 FR 49507, 49510 (1999) (collecting cases) (The Agency “has previously held that misconduct which does not involve controlled substances may constitute grounds, under 21 U.S.C. 824(a)(5), for the revocation of a DEA Certificate of Registration.”); Melvin N. Seglin, M.D., 63 FR 70431, 70433 (1998) (“[M]isconduct which does not involve controlled substances may constitute grounds for the revocation of a DEA registration pursuant to 21 U.S.C. 824(a)(5).”), Stanley Dubin, D.D.S., 61 FR 60727, 60728 (1996) (Registration revoked and pending applications for renewal denied when registrant's “actions cast substantial doubt on . . . [his] integrity.”); George D. Osafo, M.D., 58 FR 37508, 37,509 (1993) (Submission of fraudulent medical claims and larceny convictions indicated that registrant “placed monetary gain above the welfare of his patients, and in so doing, endangered the public health and safety.”).

Under 42 U.S.C. 1320a-7(a)(1), the HHS OIG is required to exclude from participation in any Federal health care program any individual who has been convicted of a criminal offense “related to the delivery of an item or service under . . . [42 U.S.C. 1395 et seq.] or under any State health care program.” As found above, Respondent has been excluded from participation in any Federal health care program based on his “conviction . . . of a criminal offense related to the delivery of an item or service under the Medicare or a State health care program,” GX 5, at 1, and this is a mandatory exclusion subject to 21 U.S.C. 824(a)(5). Accordingly, I hold that DEA's evidence satisfies its prima facie burden to support revocation of Respondent's registration.

Sanction

Where, as here, DEA has established grounds to revoke a registration or deny an application, a respondent must then “present[ ] sufficient mitigating evidence” to show why he can be entrusted with a registration. Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). “ `Moreover, because “past perform